Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. Job Summary This is a laboratory testing position with the major responsibilities include daily testing per SOP, protocol-driven non-routine testing, peer data review, writing/revising standard operating procedures, scheduling lab activities, investigating aberrances and providing/implementing compliant solutions, technical writing, and general laboratory maintenance and upkeep. This is a limited-term position expected to last approximately 12 months. Employment is anticipated to conclude at the end of the assignment, subject to business needs. Job Responsibilities Technical Expertise: &bull; Has core understanding of applicable compliance/guidance/regulations (ISO, USP, FDA, EU). &bull; Demonstrates proficiency in moderately complex methods such as ELISA, Cell Culture, Plaque assays, CCIT, KF, pH, etc. &bull; Executes laboratory tests and other lab activities to ensure timely delivery of results to internal and external customers. &bull; Work with Management to coordinate scheduling of laboratory activities &bull; Ability to Investigate and determine Root Cause associated with laboratory deviations. &bull; Executes Change Controls, CAPAs, and Effectiveness Checks &bull; Executes validation studies; obtain and interpret validation data. &bull; Maintains laboratory equipment as per established procedure Laboratory Support (Including Quality Systems): &bull; Initiates change and continuous improvement using LEAN practices such as 5S and Kaizen. &bull; Works with facilities/metrology to conduct and document execution of work orders to ensure GMP compliant state of labs and equipment. &bull; Uses GMP and scientific expertise to lead internal (department and site) audit activities. &bull; Performs as supporting personnel and/or acts as lead under guidance of management or higher level scientific personnel. &bull; May provide guidance to lower level personnel. &bull; Performs laboratory instrument calibration in accordance with established procedures. &bull; Represents QC in vendor relations, including contract support and working with vendors during validation (IOPQ) and calibration. &bull; May perform scheduling to ensure critical QC metrics are consistently met for product turnaround times. &bull; Quality Systems: &bull; Reviews and Verifies QC data. &bull; Author/revise and contributes test methods; SOPs; specifications; protocols, technical studies or reports. &bull; Author laboratory investigations and non-conformance. &bull; Supports CAPA and change control through participation in project planning and collaboration. Problem Solving: &bull; Works on problems of diverse scope requiring evaluation of identifiable factors. &bull; Exercises judgment within defined procedures and practices to determine appropriate action. &bull; Receives no instruction on routine work, general instructions on new assignments. Behavior/Cultural Responsibilities: &bull; Ownership - Actively participate in self-development &bull; Accountability - Follow through on commitments, Situational Leadership or additional accountability tools &bull; Detail oriented - Able to complete required tasks and associated documentation with minimal error &bull; Adaptability - Maintain positive attitude in a changing work environment &bull; Communication - Effectively communicate with all levels of manufacturing and support staff &bull; Actively participate in department / level meetings &bull; Escalate issues through the proper channels &bull; Live the Core Values The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. Education, Experience & Skills &bull; Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws. &bull; Bachelors or Master's degree in a scientific discipline &bull; Minimum of 5 years of related experience &bull; Hands-on experience with one or more assays and instruments: cell-based toxin neutralization assays, animal handling and dosing, and cell culture &bull; Strong technical and communication skills: oral/written and listening &bull; Personal Competencies: Self-awareness, Integrity, Team Player, Creative, and Flexible. &bull; Computer skills (MS Office, JMP statistical software, Visio, MS Project) U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $70,500 to $85,200 . . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

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Analyst II, QC Analytical (Limited Term)

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. Job Summary This is a laboratory testing position with the major responsibilities being daily environmental/utility and microbiology testing, quality systems support, and inter-departmental scientific support. Works on complex and varied problems/projects requiring in depth analysis and interpretation. Responsibilities Technical Expertise: o Has core understanding of applicable compliance/guidance/regulations (ISO, USP, FDA, EU). o Executes laboratory tests and other lab activities to ensure timely delivery of results to internal and external customers.Testing includes Sterility, Bioburden, endotoxin (gel clot), growth promotion, biological indicator testing. o Environmental Monitoring, Utilities and Gas sampling and testing. o Demonstrates proficiency in moderately complex methods such as microbial identification, Bacteriostasis & Fungistasis, Inhibition/Enhancement,Microbial Limits testing, growth promotion. o Executes validation studies, obtain and interpret validation data following microbial guidance documents. o Conducts laboratory investigations, knowledge of RCA tools, CAPAs, and CCRs Laboratory Support (Including Quality Systems): o Initiates change and continuous improvement using LEAN practices such as 5S and Kaizen. o Compiles and analyzes EM/Utility Data and write Quarterly/Annual Reports o Compiles trend analysis for Metrics as needed, and write associated reports for internal and regulatory. o Uses GMP and scientific expertise to lead internal (department and site) audit activities. o Mentor and provide guidance to junior personnel. o Performs laboratory instrument calibration in accordance with established procedures. o Independently investigates Microbiology testing and equipment issues, and implements CAPAs and CCRs as appropriate o Represents QC in vendor relations, including contract support and working with vendors during validation (IOPQ) and calibration. o Ensure critical QC metrics are consistently met for product turnaround times. Quality Systems: o Peer Reviews and Verification of QC data. o Author/revise and contributes test methods; SOPs; specifications; protocols, technical studies or reports. o Author laboratory investigations and non-conformance. o Supports CAPA and change control through participation in project planning and collaboration. Problem Solving: o Works on problems of diverse scope requiring evaluation of identifiable factors. o Exercises judgment within defined procedures and practices to determine appropriate action. o Receives minimal instruction on routine work, general instructions on new assignments. Behavior/Cultural Responsibilities: o Ownership - Actively participate in self-development o Accountability - Follow through on commitments, Situational Leadership or additional accountability tools o Detail oriented - Able to complete required tasks and associated documentation with minimal error o Adaptability - Maintain positive attitude in a changing work environment o Communication - Effectively communicate with all levels of manufacturing and support staff o Actively participate in department / level meetings o Escalate issues through the proper channels o Live the Core Values The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. Education, Experience & Skills &bull; Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws. &bull; Bachelor or Master Degree in an applied science (microbiology preferred). &bull; 2 - 5 years of experience preferred, or equivalent level of skill and experience. &bull; Previous experience with microbiology assays and aseptic techniques in a GMP manufacturing environment is preferred. &bull; Hands-on experience with one or more microbiology techniques: membrane filtration, inoculation (broth/agar), serial dilutions, biochemical tests, microbial identification, enumeration, environmental monitoring. &bull; Personal Competencies: self-awareness, integrity, team player, innovative, and flexible. &bull; An understanding of cGMP, CFR, USP, and aseptic processing guidelines is required. &bull; Require good written and verbal communication skills, good team work skills &bull; Computer skills (MS Office, MS Project) or comparable word-processing and spreadsheet applications is required. &bull; May require work on weekends, and nights. U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $70,500 to $85,200 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Analyst II, QC Micro

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. JOB SUMMARY This is an on-site laboratory testing position with the major responsibilities being daily testing, quality systems support, and inter-departmental scientific support. Works on complex and varied problems/projects requiring in depth analysis and interpretation. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Overview:<ul> <li>Sample, label, test, send for external testing, and release of incoming raw materials utilizing LIMS.</li> <li>Support laboratory through the maintenance of laboratory, equipment, and test methods per approved procedures. </li> <li>Own and drive to completion: <ul> <li>quality notifications and tasks in the quality management system (deviations, CAPA, Change Controls, Effectiveness Checks) creation of new documents and document updates</li> <li>Performance of material qualification tasks (testing, report generation)</li> </ul> </li> </ul>Technical Expertise:<ul> <li>Has understanding of applicable compliance/guidance/regulations (ISO, USP, FDA, EU).</li> <li>Demonstrates proficiency in simple methods such as physical inspection, pH, dimensional analysis and appearance and moderately complex methods such as FTIR, Titration, UV Vis</li> <li>Spectrophotometry, Gel Electrophoresis, HPLC, and Loss on Drying.</li> <li>Ability to follow written procedures and execute laboratory methods including wet chemistry techniques.</li> <li>Experience using LIMS to manage samples and document testing results.</li> <li>Executes laboratory tests and other lab activities to ensure timely delivery of results to internal and external customers.</li> <li>Ability to Investigate and determine Root Cause associated with laboratory deviations.</li> <li>Executes Change Controls, CAPAs, and Effectiveness Checks</li> <li>Executes validation studies; obtain and interpret validation data.</li> <li>Maintains laboratory equipment as per established procedure</li> </ul>Laboratory Support (Including Quality Systems):<ul> <li>Initiates change and continuous improvement using LEAN practices such as 5S and Kaizen.</li> <li>Works with facilities/metrology to conduct and document execution of work orders to ensure GMP compliant state of labs and equipment.</li> <li>Uses GMP and scientific expertise to lead internal (department and site) audit activities.</li> <li>Performs as supporting personnel and/or acts as lead under guidance of management or higher-level scientific personnel.</li> <li>May provide guidance to lower level personnel.</li> <li>Performs laboratory instrument calibration in accordance with established procedures.</li> <li>Represents QC in vendor relations, including contract support and working with vendors during validation (IOPQ) and calibration.</li> <li>May perform scheduling to ensure critical QC metrics are consistently met for product turnaround times. </li> </ul>Quality Systems:<ul> <li>Reviews and Verifies QC data.</li> <li>Author/revise and contributes test methods; SOPs; specifications; protocols, technical studies or reports.</li> <li>Author laboratory investigations and non-conformance.</li> <li>Supports CAPA and change control through participation in project planning and collaboration.</li> </ul>Problem Solving:<ul> <li>Works on problems of diverse scope requiring evaluation of identifiable factors.</li> <li>Exercises judgment within defined procedures and practices to determine appropriate action.</li> <li>Follows good laboratory practices and procedures in analyzing situations or data from which answers can be readily obtained</li> <li>Receives no instruction on routine work, general instructions on new assignments.</li> </ul>Behavior/Cultural Responsibilities:<ul> <li>Ownership - Actively participate in self-development</li> <li>Accountability - Follow through on commitments, Situational Leadership or additional accountability tools</li> <li>Detail oriented - Able to complete required tasks and associated documentation with minimal error</li> <li>Adaptability - Maintain positive attitude in a changing work environment</li> <li>Communication - Effectively communicate with all levels of manufacturing and support staff</li> <li>Actively participate in department / level meetings</li> <li>Escalate issues through the proper channels</li> <li>Live the Core Values</li> </ul>The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS<ul> <li>Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.</li> <li>Bachelor's or master's degree in an applied science (chemistry preferred).</li> <li>3 - 5 years of experience preferred, or equivalent level of skill and experience.</li> <li>Previous hands-on experience with Raw Material assays in a GMP manufacturing environment is preferred.</li> <li>Personal Competencies: self-awareness, integrity, team player, innovative, and flexible.</li> <li>An understanding of cGMP, CFR, and USP is required.</li> <li>Require good written and verbal communication skills, good teamwork skills</li> <li>Computer skills (MS Office, MS Excel, MS Project) or comparable word-processing and spreadsheet applications is required.</li> </ul> U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $70,500 to $85,200 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Analyst II, QC Raw Materials

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. Job Summary This is a laboratory testing position with the major responsibilities include maintain testing process optimization, implementing new microbiology initiatives as needed, quality systems support, and inter-departmental scientific support. The position also supports daily environmental/utility and microbiology testing as needed. Works on complex and varied problems/projects requiring in depth analysis and interpretation. Responsibilities Technical Expertise: o Has core understanding of applicable compliance/guidance/regulations (ISO, USP, FDA, EU). o Executes laboratory tests and other lab activities to ensure timely delivery of results to internal and external customers. Testing includes Sterility, Bioburden, endotoxin (gel clot), growth promotion, biological indicator testing. o Environmental Monitoring, Utilities and Gas sampling and testing. o Demonstrates proficiency in moderately complex methods such as microbial identification, Bacteriostasis & Fungistasis, Inhibition/Enhancement, Microbial Limits testing, growth promotion. o Executes validation studies, obtain and interpret validation data following microbial guidance documents. o Coordinates and processes departmental change controls o Conducts laboratory investigations, knowledge of RCA tools, CAPAs, and CCRs Laboratory Support (Including Quality Systems): o Initiates change and continuous improvement using LEAN practices such as 5S and Kaizen. o Compiles and analyzes EM/Utility Data and write Quarterly/Annual Reports o Compiles trend analysis for Metrics as needed, and write associated reports for internal and regulatory. o Uses GMP and scientific expertise to lead internal (department and site) audit activities. o Mentor and provide guidance to junior personnel. o Performs laboratory instrument calibration in accordance with established procedures. o Independently investigates Microbiology testing and equipment issues, and implements CAPAs and CCRs as appropriate o Represents QC in vendor relations, including contract support and working with vendors during validation (IOPQ) and calibration. o Ensure critical QC metrics are consistently met for product turnaround times. Quality Systems: o Peer Reviews and Verification of QC data. o Author/revise and contributes test methods; SOPs; specifications; protocols, technical studies or reports. o Author laboratory investigations and non-conformance. o Supports CAPA and change control through participation in project planning and collaboration. Problem Solving: o Works on problems of diverse scope requiring evaluation of identifiable factors. o Exercises judgment within defined procedures and practices to determine appropriate action. o Receives minimal instruction on routine work, general instructions on new assignments. Behavior/Cultural Responsibilities: o Ownership - Actively participate in self-development o Accountability - Follow through on commitments, Situational Leadership or additional accountability tools o Detail oriented - Able to complete required tasks and associated documentation with minimal error o Adaptability - Maintain positive attitude in a changing work environment o Communication - Effectively communicate with all levels of manufacturing and support staff o Actively participate in department / level meetings o Escalate issues through the proper channels o Live the Core Values The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. Education, Experience & Skills &bull; Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws. &bull; Bachelor or Master Degree in an applied science (microbiology preferred). &bull; 5 - 7 years of experience preferred, or equivalent level of skill and experience. &bull; Previous experience with microbiology assays and aseptic techniques in a GMP manufacturing environment is preferred. &bull; Hands-on experience with one or more microbiology techniques: membrane filtration, inoculation (broth/agar), serial dilutions, biochemical tests, microbial identification, enumeration, environmental monitoring. &bull; Personal Competencies: self-awareness, integrity, team player, innovative, and flexible. &bull; An understanding of cGMP, CFR, USP, and aseptic processing guidelines is required. &bull; Require good written and verbal communication skills, good team work skills &bull; Computer skills (MS Office, MS Project) or comparable word-processing and spreadsheet applications is required. &bull; May require work on weekends, and nights. U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $84,000 to 101,700 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Analyst III, QC Micro

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. JOB SUMMARY Perform methods and procedures for inspecting, testing, and evaluating raw materials. Support program improvements including SOPs, new test methods, improved specifications, raw material qualification program, and alignment of raw material procurement with other Emergent sites. Streamline and improve compliance and efficiency in Quality Control programs and develop, implement, and maintain quality control systems and activities. Conduct out-of-specification and failure investigations, recommend, and implement corrective actions. Responsible for generations, tracking, and completion of quality investigations and compliance records for the QC department. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.<ul> <li>Supports the implementation of the raw material program at EMOB.</li> <li>Leads change for revision of existing tests and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.</li> <li>Assesses compendial changes; leads change for revision of existing assays and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.</li> <li>Perform daily activities in routine sampling raw materials, testing of raw materials and cleaning lab(weekly/monthly).</li> <li>Well versed in a wide variety of analytical and compendial methodologies and techniques such as FTIR, pH measurement, refractometry, density/specific gravity measurement using density meter, UV-VIS, distillation, titrations, AKTA, HPLC and GC.</li> <li>Perform entering sample and result of raw materials into Lims Lab Vantage system.</li> <li>Communicate and coordinate with third parties and/or other departments.</li> <li>Prepares specifications, SOPs, and method verification protocols and reports.</li> <li>Ships samples and monitors test results produced by contract testing laboratories</li> <li>Communicates with raw material manufacturers to implement testing methodologies at EMOB.</li> <li>Perform daily activities in routine sampling raw materials, testing of raw materials and cleaning samples.</li> <li>Performs required data analysis, compiles data, and prepares results for review</li> <li>Conducts wet chemistry, chromatographic, and spectroscopic testing.</li> <li>Performs other duties as assigned in support of QC Laboratory operations such as facilities qualification and routine monitoring testing, as well as QC testing, data reviews, sampling, and maintaining QC laboratory systems, when appropriately trained and qualified.</li> <li>Supports raw material testing equipment and instrument qualification, calibration, and preventive maintenance, as assigned.</li> <li>Lead Period Review, OOS, deviations, Change Control, and CAPAs; designs and implements corrective action plans to address deficiencies. </li> </ul>The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS<ul> <li>Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.</li> <li>Bachelor's Degree in Chemistry or closely related scientific discipline with at least 5 years of relevant experience or Master's Degree with a minimum of 3 years of relevant experience. (Mainly QC Raw Material background)</li> <li>Experience with spectroscopic methods, chromatography, and wet chemistry methods.</li> <li>Familiarity with global pharmacopeias and monograph testing.</li> <li>Ability to follow SOPs and comply with cGMPs; generate SOPs.</li> <li>Experience with implementing compendial test methods and performing a variety of analyses including computer-based instrumental analytics.</li> <li>Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports.</li> <li>Requires the ability to execute raw material assay methodologies including spectroscopy, wet chemistry, and chromatography.</li> <li>Experience working in a pharmaceutical testing environment.</li> <li>Requires good technical writing skills and the ability to effectively communicate with manufacturing, materials management, and quality assurance staff.</li> <li>Proficient in Microsoft Office - Word, Excel, PowerPoint.</li> <li>Comprehensive knowledge of pharmaceutical GLPs and GMPs.</li> <li>Comprehensive knowledge of laboratory techniques and safety precautions.</li> <li>Comprehensive knowledge of regulatory/industry guidance.</li> </ul> U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $84,000 to $101,700 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Analyst III, QC Raw Materials

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. JOB SUMMARY The Custodian and Grounds Technician is responsible for maintaining all non-GMP areas of the interior/exterior facility in a clean, healthy, audit ready state. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.<ul> <li>Clean all administrative and common areas: empty garbage, clean floors, dust, clean windows, etc. as required.</li> <li>Perform scheduled and unscheduled preventative maintenance tasks in SAP related to cleaning.</li> <li>Maintain detailed cleaning logs for all areas of responsibility.</li> <li>Perform snow removal and landscaping assignments, as required. </li> <li>May oversee contractors employed to perform the general maintenance and repairs to the facility and grounds. </li> <li>Maintain all material, supplies and equipment used to maintain the facility.</li> <li>Participate in and maintain all required job specific and safety training.</li> <li>Maintain a current and detailed knowledge of cGMP.</li> <li>Seek ways to increase operational efficiency.</li> <li>Participate in special projects as required.</li> <li>Other duties as assigned by the custodial supervisor.</li> <li>Assists with continuous improvement projects within the department</li> </ul>The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS<ul> <li>Completion of Grade 12 from an accredited educational institution preferred combined with minimum 1 year of related experience.</li> <li>Experience in a pharmaceutical manufacturing environment is an asset.</li> <li>Good working knowledge of janitorial functions and the ability to operate powered cleaning equipment.</li> <li>Strong interpersonal and communication skills.</li> <li>Cooperative approach to teamwork with emphasis on successfully completing site goals and providing strong customer service to internal stakeholders.</li> <li>Strong organizational and planning skills with a great attention to detail.</li> </ul> U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $34,000 to $41,200 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Custodial & Grounds Technician

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. I. JOB SUMMARY The Enterprise Data Architect and Technical Lead is a strategic and hands-on leadership role within the Enterprise Information Management (EIM) team. This position is responsible for defining and driving the enterprise data architecture vision for scalable, high-quality data solutions. The role combines deep expertise in data modeling, middleware, MDM, and visualization with the ability to lead through influence-collaborating closely with ETL developers, data engineers, and BI developers across a multidisciplinary environment to drive outcomes. The successful candidate will oversee the design and implementation of the Enterprise Data Warehouse - inclusive of data products (EDW), enterprise integration layer (ie, middleware), MDM, and ensuring that data platforms are aligned with business objectives, optimized for performance, and governed by best practices. This role will also guide the technical execution of data projects, manage resource allocation, and foster collaboration across functional and IT teams. II. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Data Architecture, MDM, Middleware & Strategy &bull; Own the architecture, implementation, and delivery of the Enterprise Data Warehouse (EDW) &bull; Knowledgeable on middleware & ETL technologies and ability to partner with vendors to implement capabilities &bull; Deep understanding of MDM technologies and how to integrate into an organizational operational processes &bull; Translate business requirements into scalable data architecture and actionable technical plans &bull; Define and enforce data standards, lineage, and attribute mapping across systems &bull; Design logical and dimensional data models (e.g., data products such as Customer360) to support enterprise reporting and analytics &bull; Build and maintain a comprehensive data dictionary and metadata repository &bull; Conduct in-depth data analysis using SQL and other tools to validate and audit data quality &bull; Ensure adherence to best practices in data governance, security, and performance optimization Collaboration & Communication &bull; Work closely with functional partners and IT business analysts to understand requirements and translate them into technical solutions &bull; Communicate technical concepts clearly to both technical and non-technical audiences &bull; Partner with other IT teams to ensure seamless integration across systems and platforms &bull; Work independently and proactively in a fast-paced, deadline-driven environment The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS<ul> <li>Bachelor's degree in Computer Science, Information Systems, Engineering, Business, or a related field or equivalent experience in a technical or business discipline.</li> <li>10-15 years' experience with following tools and concepts <ul> <li>Databases such as SQL Server / Oracle</li> <li>ETL or Middleware software such as Informatica, Mulesoft</li> <li>Columnar databases such as Snowflake / Vertica</li> <li>Data Modeling tools such as ERWin or ER Studio</li> <li>Processing large volumes of structured and unstructured data</li> <li>Data movement and transformation technologies</li> <li>Version Control software such as TFS, CVS or GIT (preferred)</li> </ul> </li> <li>Strong analytics skills</li> <li>Strong written and verbal communication skills.</li> <li>Sound business and technical acumen</li> <li>Strong time management, organization, and execution skills</li> <li>Ability and desire to work in a fast paced, dynamic environment</li> <li>Strong collaboration skills required to effectively work across a diverse group including executives, managers and subject matter experts</li> <li>Self-starter who takes initiative to get tasks done</li> <li>Prior experience in the following areas is highly desirable <ul> <li>SAP functional modules (Finance/Accounting, Supply Chain, Materials Management, Warehouse Management, Procure to Pay)</li> <li>Delivering BI / DW solutions to end users in the pharmaceutical industry</li> </ul> </li> </ul>Abilities: Demonstrated capabilities (e.g. able to translate strategy to action, Effective verbal and/or written communicate at all levels of organization, work effectively in ambiguous situations, ability to multi-task, proven track record of increasing customer base) LI - #remote U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from [ $155,500 to $188,200] . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Enterprise Data Architect & Technical Lead (remote)

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. I. JOB SUMMARY The Lead for Governance, Risk and Compliance will oversee cybersecurity governance, risk management and compliance processes including the data protection and security awareness training programs. This position is an individual contributor role, reporting to the IT Vice President and CISO at Emergent. This role will initially focus on maturing enterprise-wide data protection capabilities, including data classification, data loss prevention, information protection and data governance frameworks. Over time, the role will expand to support Manufacturing OT security and oversee broader GRC functions, including cybersecurity risk management, regulatory compliance, security policies and standards and security governance. The ideal candidate combines strong cybersecurity expertise with program leadership, executive communications and experience implementing security programs leveraging governance and technologies. This position will be hands-on and require strong collaboration with various IT and business functions to satisfy our governance, risk management and compliance processes. This position is full-time remote. II. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Data Protection <ul> <li>Lead implementation and governance of technologies supporting: Data Classification and Labeling, Data Loss Prevention (DLP), Insider Risk Management, Data Discovery and Inventory, Records and </li> </ul>Information Management<ul> <li>Partner with business stakeholders to identify, classify, and protect information</li> <li>Establish governance processes for data owners, custodians, and users</li> <li>Define data protection metrics, KPIs, and reporting for executive leadership</li> <li>Lead remediation efforts for large volumes of inadequately protected data</li> <li>Oversee data protection policy compliance across all technology platforms</li> <li>Drive adoption of data protection capabilities via training and change management</li> </ul>Governance<ul> <li>Lead the organization on improved maturity with regards to IS27001, CMMC or related industry certifications based on the NIST framework.</li> <li>Lead cybersecurity maturity assessments and create/maintain cybersecurity KPI and metrics for efficient decision making with functional leaders </li> <li>Establish and maintain cybersecurity governance frameworks and operating models.</li> <li>Support various cyber councils, governance forums and program steering committees</li> <li>Collaborate with IT and functional leaders to align cybersecurity initiatives with business objectives</li> </ul>Risk Management<ul> <li>Create and maintain the Cybersecurity risk register and support risk quantification and prioritization efforts that are appropriate for the environment</li> <li>Partner with business leaders to evaluate technology, operational, third-party, data-related risks and document risk assessments and their approvals</li> <li>Support risk reporting dashboards for executive management and governance councils</li> <li> Assist the vulnerability management program to document risks and plans of actions.</li> </ul>Policies & Communications <ul> <li>Lead, own and develop new information security policies and review existing policies for updates and approvals</li> <li>Lead, maintain and continuously improve security awareness and training programs, cybersecurity company-wide campaign, and</li> <li>Lead cybersecurity audits internally and develop readiness activities. Support internal and external audits and assessments.</li> </ul>Manufacturing Security<ul> <li>Support the manufacturing security program workstreams around network segmentation, secure remote access, logging and OT incident management. </li> <li>Create and lead the cyber training and awareness for manufacturing sites</li> <li>Support the execution of periodic BCP and Cybersecurity table top exercises The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. </li> </ul>III. MINIMUM EDUCATION, EXPERIENCE, SKILLS Education: <ul> <li>Bachelor's Degree in Business or Information Systems, or equivalent experience.</li> </ul>Experience: <ul> <li>5+ years in cybersecurity, compliance, risk management or 7+ years of related/industry experience </li> <li>Experience leading cybersecurity projects and programs</li> <li>Experience working with cybersecurity tools, methodologies and technologies</li> </ul>Knowledge: <ul> <li>Experience supporting cybersecurity programs within manufacturing environments, including familiarity with cybersecurity risks associated with industrial operation</li> <li>Must understand network and computing, vulnerability management, IAM/PAM</li> <li>Must be familiar with Sarbanes Oxley (SOX), SSAE 18 SOC reports, NIST CSF, ISO27001 and CMMC </li> </ul>Skills: <ul> <li>Strong interpersonal and collaboration skills to work well with all IT and business stakeholders</li> <li>Strong communication skills (oral, written, presentation) to influence across all levels of the organization </li> <li>Adequate program management and organizational skills to ensure accuracy and timeliness of job duties</li> <li>Must be able to author policy documents, provide business risk assessments, and communicate well with other teams.</li> <li>Must be able to identify sensitive information, such as PII, PHI, Clinical Data, etc.</li> </ul>Abilities: <ul> <li>Demonstrated experience working across organizations to resolve conflicts</li> <li>Demonstrated experience with organization-wide communications.</li> <li>Demonstrated experience managing and documenting security risks.</li> </ul> U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from [ $155,500 to $188,200] . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Lead, Governance, Risk & Compliance (Remote)

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. JOB SUMMARY The Manager, Environment, Health & Safety (EH&S) serves as the site leader and primary subject matter expert for all EH&S programs at the Canton, Massachusetts GMP vaccine drug substance (DS) manufacturing site. Operating as an individual contributor, this role has full ownership for establishing, implementing, and sustaining EH&S systems to support safe site start-up, regulatory readiness, and routine commercial operations. The Manager is accountable for ensuring compliance with OSHA, EPA, MassDEP, CDC/NIH, and all applicable federal, state, and local regulations, permits, and registrations. This role partners cross-functionally with Site Leadership, Manufacturing, Quality, Engineering, and external agencies to enable compliant, efficient, and safe manufacturing operations while driving a proactive, risk-based safety culture aligned with cGMP expectations. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.<ul> <li>Serve as the site EH&S leader and single point of accountability for all environmental, health, and safety programs during site start-up, ramp-up, and steady-state GMP operations.</li> <li>Lead the development, implementation, and continuous improvement of EH&S programs, policies, and procedures to support a GMP-compliant vaccine drug substance manufacturing environment.</li> <li>Ensure full compliance and ongoing readiness for OSHA, EPA, MassDEP, local fire department, and other regulatory inspections; own all site EH&S permits, licenses, and regulatory reporting obligations.</li> <li>Act as the primary liaison with regulatory authorities, auditors, and external partners; lead site inspections, responses, and closure of commitments.</li> <li>Provide strategic and hands-on EH&S support to site start-up activities including facility readiness, commissioning, qualification, and operational risk assessments.</li> <li>Lead and execute comprehensive EH&S risk assessments (e.g., JSA, process hazard analysis, biosafety assessments) to identify and mitigate risks associated with biologics manufacturing, laboratories, utilities, and support functions.</li> <li>Own incident management processes including investigations, root cause analysis, and implementation of effective corrective and preventive actions; ensure timely reporting and closure.</li> <li>Establish and monitor EH&S performance metrics; analyze trends and provide data-driven insights and recommendations to site leadership.</li> <li>Develop and maintain environmental compliance programs including hazardous waste, wastewater discharge, air emissions, stormwater, and chemical inventory/SDS systems.</li> <li>Oversee occupational health and industrial hygiene programs including medical surveillance, respiratory protection, ergonomics, exposure monitoring, and hearing conservation.</li> <li>Lead contractor safety and permit-to-work programs (e.g., hot work, confined space, line break), ensuring safe execution of construction, maintenance, and engineering activities.</li> <li>Review and approve SOPs, change controls, deviations, and capital projects to ensure EH&S risks are identified and controlled in alignment with GMP requirements.</li> <li>Support and influence site culture by driving EH&S engagement, training programs, and leadership visibility across all levels of the organization.</li> <li>Collaborate with corporate EH&S and functional partners to align site practices with enterprise standards, regulatory expectations, and industry best practices.</li> <li>Serve as responsible or alternate official for biosafety, biosecurity, and select agent programs, as applicable to vaccine drug substance operations.</li> </ul>The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS<ul> <li> Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws. </li> <li>Bachelor's degree in Environmental Health & Safety, Industrial Hygiene, Environmental Science, Engineering, Biology, Chemistry, or related technical discipline required; advanced degree preferred.</li> <li>Minimum of eight (8) years of progressive EH&S experience, including demonstrated ownership of site-level EH&S programs in a regulated manufacturing environment.</li> <li>Strong experience in cGMP pharmaceutical, vaccine, biologics, or biotechnology manufacturing operations, including start-up or facility commissioning experience.</li> <li>Deep knowledge of OSHA, EPA, and state/local environmental regulations (MassDEP experience preferred), including permitting, inspections, and regulatory reporting.</li> <li>Proven track record of leading EH&S related inspections and audits and successfully managing responses and corrective actions.</li> <li>Experience managing EH&S risks in biologics or vaccine drug substance environments, including biosafety, chemical hazards, and high-containment considerations.</li> <li>Strong working knowledge of EH&S management systems and frameworks (e.g., ISO 14001, ISO 45001) and their integration into GMP operations.</li> <li>Demonstrated ability to operate independently as a site EH&S lead, prioritize competing demands, and drive results in a fast-paced environment.</li> <li>Excellent communication, influencing, and stakeholder management skills, with the ability to effectively engage senior leadership, regulators, and cross-functional teams.</li> <li>Professional certification such as CSP, CIH, CHMM, or equivalent strongly preferred or ability to obtain within a defined timeframe.</li> </ul> If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled. U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $129,000 to $151,500 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

Manager, EHS

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. JOB SUMMARY The Manager, Manufacturing is responsible for end-to-end leadership and execution of upstream drug substance operations within a CGMP vaccine manufacturing environment. This role ensures equipment and material readiness, media preparation, cell culture, infection processes, and execution oversight while maintaining strict compliance with regulatory requirements. The incumbent will lead a team of manufacturing professionals, drive operational excellence, collaborate with other SMEs, ensure inspection readiness, and deliver safe, compliant, and reliable production in alignment with site objectives. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.<ul> <li>Provide direct leadership and oversight of upstream manufacturing operations including media preparation/transfer, cell culture, infection, harvest, and associated process steps.</li> <li>Ensure full readiness of equipment, materials, and personnel to support production schedules and batch execution.</li> <li>Lead and oversee all aspects of execution on the manufacturing floor, ensuring adherence to batch records, SOPs, and CGMP requirements.</li> <li>Own and manage Quality Management System (QMS) elements including deviations, CAPAs, change controls, and investigations.</li> <li>Ensure all documentation (batch records, logbooks, and supporting records) is accurate, complete, and inspection-ready.</li> <li>Drive compliance with global regulatory requirements (FDA, MFDS, TGA, and other applicable agencies). Lead people management responsibilities including hiring, coaching, performance management, and development of direct reports.</li> <li>Establish a culture of safety, quality, and continuous improvement across upstream operations.</li> <li>Oversee cleaning, decontamination, sterilization, and aseptic practices to maintain a compliant manufacturing environment.</li> <li>Partner cross-functionally with MSAT, Quality, Supply Chain, Engineering, and QA to ensure successful execution and continuous improvement.</li> <li>Drive operational excellence initiatives including cycle time reduction, right-first-time performance, and capacity optimization.</li> <li>Support regulatory inspections and audits, ensuring sustained inspection readiness.</li> </ul>The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.<ul> <li>Bachelor's degree in Life Sciences, Engineering, or a related discipline required (advanced degree preferred).</li> <li>Minimum of 7+ years of experience in biopharmaceutical or vaccine manufacturing, with at least 3 years in a leadership role.</li> <li>Strong experience in upstream processing including cell culture and viral systems preferred.</li> <li>Deep knowledge of CGMP regulations, FDA guidelines, and global regulatory expectations.</li> <li>Proven experience managing teams in a regulated manufacturing environment.</li> <li>Demonstrated ability to lead investigations, implement CAPAs, and manage complex Quality Systems.</li> <li>Strong communication, leadership, and stakeholder management skills.</li> </ul>CORE COMPETENCIES<ul> <li>Operational leadership and execution focus</li> <li>Strategic thinking with strong tactical delivery</li> <li>Quality and compliance mindset</li> <li>People leadership and team development</li> <li>Problem-solving and decision-making under pressure</li> <li>Continuous improvement orientation</li> </ul> If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled. U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $129,000 to $151,500 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

Manager, Upstream Manufacturing

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. JOB SUMMARY Execute tasks per CGMP guidelines and Standard Operating Procedures to manufacture, inspect and package Anthrax Vaccine Adsorbed. Complete training and maintain competence per the manufacturing training program. Actively incorporate the Shared Values set out by Emergent BioSolutions while performing day to day activities. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. General<ul> <li>Complete training and demonstrate competency on Manufacturing Associate qualification blocks in accordance with the training progression pathway</li> <li>Execute and document procedural steps in compliance with CGMP standards, clean room behavior and Standard Operating Procedures</li> <li>Comply with all applicable rules and regulations of Emergent and the Pharmaceutical / Biotech industry. This includes FDA regulations such as CGMP, GDP, EH&S regulations, and company regulations such as the employee handbook</li> <li>Maintain state of facility environmental control including: preparation of defined concentrations of cleaning solutions, daily, monthly, quarterly and annual cleaning of manufacturing areas per StandardOperating Procedures </li> <li>Review all documentation for accuracy and completeness of process signature steps as each step is completed. Perform real time" review of all documentation (BPRs, forms, logs, etc.) in the area throughout the shift</li> <li>Stock gowning and consumable supplies in the controlled areas maintaining Kanban inventory control of manufacturing materials</li> </ul>Lean Concepts<ul> <li>Follow standard work guidelines</li> <li>Collaborate with applicable Integrated Process Teams to participate in continuous improvement and learn new Lean concepts</li> <li>Actively participate in Kanban and 6S programs</li> </ul>Inspection and Packaging<ul> <li>Successfully complete inspector qualification requirements to identify, classify and cull product defects, including those defects which could impact patient safety (inspector qualification)</li> <li>Independently operate labeling equipment with minimal supervision (Qualification)</li> <li>Apply traceability and expiration information to secondary packaging components such as cartons and cases. Confirm suitability of secondary packaging components during printing processes through 100% inspection (carton printing, case creation)</li> <li>Package product in secondary and final packaging components while performing 100% reconciliation of product rejects (Packaging)</li> <li>Complete ambient tracking documentation</li> <li>Execute material issuance and confirmation of process steps using specific SAP modules</li> </ul>Building 55 Operations - Prep<ul> <li>Execute material issuance and confirmation of process steps using specific SAP modules</li> <li>Precisely weigh and hydrate media components</li> <li>Load, run and unload parts washer and sterilization/decontamination using specific validated load configurations per Standard Operating Procedures</li> <li>Assemble clean process glassware configurations and portable tanks utilizing sanitary connections, quick connects and stainless-steel ancillary parts</li> <li>Perform Cleaning (COP/CIP) and Sterilizing (SOP/SIP) of production vessels through interface with automated control system (DeltaV)</li> <li>Prepare and dispense intermediate materials</li> </ul>Building 55 Operations - Upstream <ul> <li>Execute detailed manual and high impact process tasks requiring extensive documentation and interface with automated controls. Process operation involves manual orientation of valve configurations and monitoring/adjustment of vessel pressures during execution to maintain the sterile envelope and create differentials to facilitate transfers. Description of specific requirements include:</li> <li>Clean and Sterilize 10L, 120L and 1320L fermenters to defined and validated parameters through interface with automated control system</li> <li>Sterilize media filters and sterile filter seed, intermediate and production media</li> <li>Inoculate 10L fermenter through addition of inoculum via peristaltic pump </li> <li>Monitor culture turbidity to verify growth to required process parameters and transfer culture from the 10L to 120L and the 120L to 1320L fermenters upon verification of achievement of these parameters</li> <li>Adjust pH of culture through manual addition of 2N NaOH aliquots to a defined pH range</li> <li>Install sterilizing grade filters, perform integrity testing and execute sterilization of filter skid</li> <li>Monitor culture turbidity to verify growth to required process parameters and filter culture from 1320L fermenter to Harvest Tank</li> </ul>Building 55 Downstream Operations<ul> <li>Add ALOH to Harvest tank.</li> <li>Draw samples and submit them through LIMS.</li> <li>Clean and sterilize Harvest Tanks</li> <li>Clean and sterilize centrifuge as well as run the centrifugation processes</li> <li>Dispense and sterilize ALOH</li> </ul>Behavior/Cultural Responsibilities<ul> <li>Standing Shoulder to Shoulder (no matter what): <ul> <li>working collaboratively with others, communicating, and managing conflict effectively</li> </ul> </li> <li>Break Through Thinking:<ul> <li>cultivating innovation and nimble learning</li> </ul> </li> <li>Own It Always:<ul> <li>ensuring accountability, and making good and timely decisions</li> </ul> </li> <li>Compete Where It Counts:<ul> <li>demonstrating courage and focusing on customers</li> </ul> </li> <li>Integrity and Instills Trust:<ul> <li>gaining the confidence and trust of others through honesty, integrity and authenticity</li> </ul> </li> <li>Manages Complexity:<ul> <li>making sense of complex, high quantity, and sometimes contradictory information to effectively solve problem</li> </ul> </li> <li>Plans and Aligns:<ul> <li>plan and prioritize work to meet commitments aligned with organizational goals</li> </ul> </li> <li>Drives Engagement:<ul> <li>creating a climate where people are motivated to do their best to help the organization achieve its objectives</li> </ul> </li> </ul>The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS<ul> <li>HS Diploma</li> <li>1-2 years' experience working in a CGMP environment </li> <li>Knowledge of CGMP and CFR requirements preferred but not required</li> <li>Personal Competencies: Self-awareness, Integrity, Team Player, Creative, and Culturally aware</li> </ul> U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $39,000 to $47,100 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Manufacturing Associate

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. JOB SUMMARY This Manufacturing Associate role is a limited term position scheduled to end in September 2027. Execute tasks per CGMP guidelines and Standard Operating Procedures to manufacture, inspect and package Anthrax Vaccine Adsorbed. Complete training and maintain competence per the manufacturing training program. Actively incorporate the Shared Values set out by Emergent BioSolutions while performing day to day activities. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. General<ul> <li>Complete training and demonstrate competency on Manufacturing Associate qualification blocks in accordance with the training progression pathway</li> <li>Execute and document procedural steps in compliance with CGMP standards, clean room behavior and Standard Operating Procedures</li> <li>Comply with all applicable rules and regulations of Emergent and the Pharmaceutical / Biotech industry. This includes FDA regulations such as CGMP, GDP, EH&S regulations, and company regulations such as the employee handbook</li> <li>Maintain state of facility environmental control including: preparation of defined concentrations of cleaning solutions, daily, monthly, quarterly and annual cleaning of manufacturing areas per StandardOperating Procedures </li> <li>Review all documentation for accuracy and completeness of process signature steps as each step is completed. Perform real time" review of all documentation (BPRs, forms, logs, etc.) in the area throughout the shift</li> <li>Stock gowning and consumable supplies in the controlled areas maintaining Kanban inventory control of manufacturing materials</li> </ul>Lean Concepts<ul> <li>Follow standard work guidelines</li> <li>Collaborate with applicable Integrated Process Teams to participate in continuous improvement and learn new Lean concepts</li> <li>Actively participate in Kanban and 6S programs</li> </ul>Inspection and Packaging<ul> <li>Successfully complete inspector qualification requirements to identify, classify and cull product defects, including those defects which could impact patient safety (inspector qualification)</li> <li>Independently operate labeling equipment with minimal supervision (Qualification)</li> <li>Apply traceability and expiration information to secondary packaging components such as cartons and cases. Confirm suitability of secondary packaging components during printing processes through 100% inspection (carton printing, case creation)</li> <li>Package product in secondary and final packaging components while performing 100% reconciliation of product rejects (Packaging)</li> <li>Complete ambient tracking documentation</li> <li>Execute material issuance and confirmation of process steps using specific SAP modules</li> </ul>Building 55 Operations - Prep<ul> <li>Execute material issuance and confirmation of process steps using specific SAP modules</li> <li>Precisely weigh and hydrate media components</li> <li>Load, run and unload parts washer and sterilization/decontamination using specific validated load configurations per Standard Operating Procedures</li> <li>Assemble clean process glassware configurations and portable tanks utilizing sanitary connections, quick connects and stainless-steel ancillary parts</li> <li>Perform Cleaning (COP/CIP) and Sterilizing (SOP/SIP) of production vessels through interface with automated control system (DeltaV)</li> <li>Prepare and dispense intermediate materials</li> </ul>Building 55 Operations - Upstream <ul> <li>Execute detailed manual and high impact process tasks requiring extensive documentation and interface with automated controls. Process operation involves manual orientation of valve configurations and monitoring/adjustment of vessel pressures during execution to maintain the sterile envelope and create differentials to facilitate transfers. Description of specific requirements include:</li> <li>Clean and Sterilize 10L, 120L and 1320L fermenters to defined and validated parameters through interface with automated control system</li> <li>Sterilize media filters and sterile filter seed, intermediate and production media</li> <li>Inoculate 10L fermenter through addition of inoculum via peristaltic pump </li> <li>Monitor culture turbidity to verify growth to required process parameters and transfer culture from the 10L to 120L and the 120L to 1320L fermenters upon verification of achievement of these parameters</li> <li>Adjust pH of culture through manual addition of 2N NaOH aliquots to a defined pH range</li> <li>Install sterilizing grade filters, perform integrity testing and execute sterilization of filter skid</li> <li>Monitor culture turbidity to verify growth to required process parameters and filter culture from 1320L fermenter to Harvest Tank</li> </ul>Building 55 Downstream Operations<ul> <li>Add ALOH to Harvest tank.</li> <li>Draw samples and submit them through LIMS.</li> <li>Clean and sterilize Harvest Tanks</li> <li>Clean and sterilize centrifuge as well as run the centrifugation processes</li> <li>Dispense and sterilize ALOH</li> </ul>Behavior/Cultural Responsibilities<ul> <li>Standing Shoulder to Shoulder (no matter what): <ul> <li>working collaboratively with others, communicating, and managing conflict effectively</li> </ul> </li> <li>Break Through Thinking:<ul> <li>cultivating innovation and nimble learning</li> </ul> </li> <li>Own It Always:<ul> <li>ensuring accountability, and making good and timely decisions</li> </ul> </li> <li>Compete Where It Counts:<ul> <li>demonstrating courage and focusing on customers</li> </ul> </li> <li>Integrity and Instills Trust:<ul> <li>gaining the confidence and trust of others through honesty, integrity and authenticity</li> </ul> </li> <li>Manages Complexity:<ul> <li>making sense of complex, high quantity, and sometimes contradictory information to effectively solve problem</li> </ul> </li> <li>Plans and Aligns:<ul> <li>plan and prioritize work to meet commitments aligned with organizational goals</li> </ul> </li> <li>Drives Engagement:<ul> <li>creating a climate where people are motivated to do their best to help the organization achieve its objectives</li> </ul> </li> </ul>The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS<ul> <li>HS Diploma</li> <li>1-2 years' experience working in a CGMP environment </li> <li>Knowledge of CGMP and CFR requirements preferred but not required</li> <li>Personal Competencies: Self-awareness, Integrity, Team Player, Creative, and Culturally aware</li> </ul> U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $39,000 to $47,100 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Manufacturing Associate - Limited Term

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. JOB SUMMARY The Specialist I, AS&T (Analytical Sciences & Technology) is responsible for supporting analytical methods and laboratory systems in a compliant state throughout their lifecycle. The role supports analytical method transfer, verification, and validation activities and contributes to analytical instrument qualification and implementation for GMP use. The Specialist I provides technical support across AST, Quality Control, and Manufacturing Technology functions to ensure compliant, reliable analytical operations. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Analytical Methods & Lifecycle Support<ul> <li>Support transfer of analytical methods, including authoring and executing method transfer, verification, and validation protocols and reports.</li> <li>Execute analytical studies, analyze and interpret data, investigate analytical issues, and contribute to effective resolutions.</li> <li>Support assessment of method performance and suitability for intended GMP use.</li> <li>Technical Writing including SOPs, Protocols, Reports</li> </ul>Instrument Qualification & Laboratory Systems<ul> <li>Support analytical instrument qualification activities, including authoring User Requirement Specifications (URS), qualification protocols/reports, and executing qualification activities.</li> <li>Support implementation and maintenance of laboratory systems in compliance with cGMP/GLP and 21 CFR Part 11 requirements.</li> <li>Support site level LIMS activities, including User Acceptance Testing (UAT) and execution of test scripts, as applicable. </li> </ul>Quality Systems & Compliance<ul> <li>Author and support laboratory investigations, deviations, CAPAs, and change controls related to analytical methods and systems.</li> <li>Support maintenance of data integrity and contemporaneous documentation in accordance with GMP expectations.</li> <li>Contribute to continuous improvement initiatives within AST laboratory operations. </li> </ul>Cross Functional Support<ul> <li>Interact with Quality Control, Manufacturing Technology, and other functional groups on technical topics and cross functional projects related to analytical sciences.</li> <li>Provide technical support as assigned to ensure timely and compliant project execution. </li> </ul>The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS<ul> <li>Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.</li> <li>Bachelor's degree in Chemistry, Biochemistry, Biology, or a related scientific discipline with at least 5 years of relevant experience.</li> <li>Must possess skills and knowledge of general immunological, bioanalytical and chemical test methods such as ELISA, qPCR, IEF, Viral and Cell-based assays, SDS-PAGE, Western Blot, DNA sequencing, microbiological methods, Sterility testing, Endotoxin testing, HPLC with multiple modes of detection, CE, and UV and IR spectroscopy.</li> <li>Advanced knowledge of USP/EP, cGMPs, 21CFR part 11, and data integrity with foundational understanding of analytical methods, laboratory instrumentation, and regulated quality systems desirable</li> <li>Experience in executing phase appropriate method qualifications and validations.</li> <li>Experience in assay method validation, equipment validation, and analytical investigation for biotherapeutic and vaccine products.</li> <li>Ability to apply statistical analysis to QC monitoring and trending</li> </ul> U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $97,500 to $117,900 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Specialist I, AS&T

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. JOB SUMMARY The QA Specialist I, Document Control is a senior individual contributor and the accountable owner of the GMP Document Control program for the Canton, MA vaccine Drug Substance (DS) manufacturing site. This role is responsible for the end-to-end governance, execution, and continuous improvement of document and records management processes in compliance with US FDA 21 CFR Parts 210, 211, and applicable global regulatory expectations. The incumbent serves as the site subject matter expert (SME) for the Electronic Document Management System (EDMS) and Good Documentation Practices (GDP), ensuring adherence to ALCOA+ principles across the document lifecycle. The role partners closely with Global Process Owners (GPOs), site Quality leadership, Manufacturing, MSAT, and other support functions to ensure global standards are effectively implemented at the site, inspection-ready at all times, and scalable to support commercial vaccine operations. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. GMP Document Control Program Ownership<ul> <li>Own and independently manage all aspects of the site GMP Document Control program, including governance, procedures, execution, and compliance oversight for controlled documents and GMP records.</li> <li>Administer and maintain the site EDMS as the primary point of contact, including document lifecycle management, system configuration support, user access control, and alignment with global processes.</li> <li>Ensure implementation and continuous adherence to Good Documentation Practices (GDP) and ALCOA+ principles across all GMP documentation.</li> </ul>Controlled Documents and Records Management<ul> <li>Manage issuance, review coordination, approval workflows, effective dating, archiving, retrieval, and retention of controlled GMP documents, including SOPs, master batch records, forms, templates, and logbooks.</li> <li>Ensure secure on-site and off-site archiving, chain of custody, traceability, and retrieval of GMP records in accordance with regulatory and internal retention requirements.</li> <li>Issue and control GMP batch documentation and executed logbooks in compliance with site procedures.</li> </ul>Quality System and Compliance Support<ul> <li>Author, review, and manage document control-related deviations, change controls, CAPAs, and effectiveness checks; provide data-driven recommendations to improve system performance.</li> <li>Develop, monitor, and report key performance indicators (KPIs) for document control processes to support Quality Management Review (QMR) and continuous improvement.</li> </ul>Training, Stakeholder Engagement, and Global Alignment<ul> <li>Provide expert guidance, training, and coaching to document authors and approvers on document standards, EDMS usage, and GDP expectations.</li> <li>Partner with Global Process Owners (GPOs) to deploy and sustain global document and records management standards, ensuring local procedures remain aligned with enterprise systems and regulatory expectations.</li> </ul>Inspection Readiness and Regulatory Support<ul> <li>Lead document control support during regulatory inspections, internal audits, and customer audits, including direct interaction with inspectors as the site SME.</li> <li>Coordinate and lead document control responses to audit observations, ensuring timely, accurate, and compliant documentation.</li> </ul>Continuous Improvement<ul> <li>Identify, lead, and implement continuous improvement initiatives to enhance document lifecycle efficiency, data integrity, inspection readiness, and user experience.</li> <li>Apply risk-based thinking to prioritize improvements and ensure a state of ongoing compliance.</li> </ul>The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS<ul> <li>Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.</li> </ul>Education and Experience<ul> <li>Bachelor's degree in Life Sciences, Quality, Information Management, or a related discipline; or equivalent education and experience.</li> <li>Minimum of 7 years of progressively responsible experience in GMP Quality Assurance, with at least 4 years focused on Document Control and records management in an FDA-regulated pharmaceutical or biotechnology environment.</li> <li>Demonstrated experience supporting commercial vaccine, biologics, or drug substance manufacturing operations strongly preferred.</li> </ul>Technical and Regulatory Expertise<ul> <li>Expert knowledge of US FDA cGMP requirements, GDP/GDocP, data integrity, and ALCOA+ principles.</li> <li>Advanced hands-on experience with Electronic Document Management Systems (e.g., Veeva Vault or equivalent), including system administration support and user training.</li> <li>Strong working knowledge of change management, deviation management, CAPA, and inspection readiness practices.</li> </ul>Core Competencies<ul> <li>Ability to operate independently with minimal supervision in a highly regulated environment while exercising sound judgment and decision-making authority.</li> <li>Excellent written and verbal communication skills, with the ability to effectively influence and partner across all organizational levels, including global stakeholders and regulators.</li> <li>Strong organizational, analytical, and problem-solving skills with a continuous improvement mindset.</li> </ul>Preferred Qualifications<ul> <li>Professional certifications such as Certified Records Manager (CRM), Document Management Certified Professional (DMCP), CMII, or ASQ Quality certifications.</li> </ul> U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $129,000 to $156,000 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Specialist I, Document Control

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. Job Summary The Specialist I, QA Compliance is responsible for independent QA oversight of each Quality System in support of commercial product manufacturing at the site and manages activities for one or more Quality System or cross-functional project. The Specialist I, QA Complance will provide a broad scope of technical knowledge to analyze risk, troubleshoot highly complex issues, support quality systems and plant compliance. They apply expertise and regulatory knowledge to support change and risk management. Essential Functions Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws. &bull; Represent the department in interactions with internal functional units and external contract partners or regulatory officials &bull; Critically review various types of documentation to ensure completeness, accuracy, and compliance including but not limited to regulatory submissions, product complaints, annual product reviews, Quality Agreements, Supplier Notifications, Request for Proposals, SOPs, master plans, deviation investigations, CAPAs and change controls &bull; Support Supplier Quality Program including conducting Supplier Audits, as assigned &bull; Develop and revise Quality Technical Agreements and supplier notification of changes to ensure impact is thoroughly assessed prior to implementation and liaise on investigations of nonconformities for suppliers providing products or services in support of GMP operations &bull; Lead or participate in cross-functional teams to address facility issues using methodical problem-solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact to product &bull; Plan, schedule and conduct internal and external (supplier) quality system audits per audit schedule. This includes a review of prior internal audits and regulatory inspections, reviewing procedures, processes and activities in creating the audit plan &bull; Drive inspection readiness strategy and activities and serve as a subject matter expert in quality systems &bull; Prepare functional and Management Review metrics for identification of negative trends. Conduct analysis of identified negative trends and propose/implement necessary corrections to address and present to Management team &bull; Frequently interacts with senior leadership, direct manager, peers, internal customers, external clients and other cross functional peers across Emergent to gain alignment on sound quality decisions. The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. Education, Experience & Skills &bull; Bachelor's Degree in Scientific or related fields &bull; A minimum of six (6) years of cGMP Quality experience &bull; Strong Commercial manufacturing experience (Large Molecules) required &bull; Quality Auditor, Six Sigma, or equivalent certification/education preferred &bull; Experienced with US, EU and Canadian pharmaceutical regulations, ISO standards &bull; Expert Knowledge and application of GMP principles &bull; Excellent communication skills: oral/written and listening &bull; Excellent facilitation and presentation skills &bull; Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability, decision making, coaching, &bull; Interpersonal skills: team building, consensus building, conflict resolution &bull; Critical analytical skills, strong verbal and communication skills &bull; Must be able to critically evaluate data summaries and conclusions &bull; Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio. &bull; Ability to influence without authority across cross-functional organization Physical/Mental Requirements Type/keyboard, visual acuity, stand, walk, sit, squat/kneel, sense of hearing, and lift/carry 15 lbs. Use phone, fax, copier and computer. Organize/coordinate, analyze/interpret, problem solve, make decisions, plan, communicate and prepare written communications. U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $129,000 to $156,000 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Specialist I, QA Compliance

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. JOB SUMMARY The Specialist I, Quality Assurance professional will be responsible for managing the quality Batch Record Review process to ensure timely completion of review, approval and closure, training of team members and management of quality binders. Responsible for Product and Raw Material Disposition process, to include coordination with QC for product specifications test results, coordination with Fill Finish site quality, 3rd party Diluent supplier and Supply Chain. In addition, the QA Specialist I will support the manager with the Complaint and APR programs at the Emergent Canton, MA site, manage the Right First Time (RFT) metrics, provide On-the-Floor support to manufacturing and a quality SME of SAP material master data. Manage and lead projects, own quality records (Deviation/CAPA/Change Control) and support additional work as required. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.<ul> <li>Review/Approve of Batch Records (including APS, Engineering and Development runs) and other related documentation.</li> <li>Disposition of Product and Raw Materials & components. Quality SME in SAP Master Data</li> <li>Manufacturing On-the-Floor support (Quality Oversight, logbook review, solve issues real time with operations personnel, etc.)</li> <li>Provide data for functional area metrics for APR and complaints among others with the objective to identify and improve system compliance and/or process challenges</li> <li>SOP generation, review and/or approval</li> <li>Own quality records (Deviation/CAPA/Change Control).</li> <li>Manage and support the Complaint program</li> <li>APR generation and approval</li> <li>Must be capable to work independently and strategically to ensure day¬ to-day activities are carried out in support of the business goals</li> <li>Lead or assist in continuous improvement projects as assigned interacts with senior leadership, direct manager, peers, internal customers, external clients and other cross functional peers across Emergent to gain alignment on sound quality decisions.</li> <li>Lead and support additional work as required.</li> </ul>The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS<ul> <li>Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.</li> <li>Bachelor's Degree in Scientific or related fields</li> <li>A minimum of five (5) years of cGMP Quality experience</li> <li>Product and Raw material disposition is a must</li> <li>Well versed in SAP is a must</li> <li>Batch Record review is a must</li> <li>Strong Commercial manufacturing experience (Large Molecules) required</li> <li>Expertise on change control, complaint management and Annual Product Review/Product Quality Review (APR/PQR) is a must</li> <li>Experienced with US, EU pharmaceutical regulations, and ISO standards</li> <li>Expert Knowledge and application of GMP principles</li> <li>Excellent communication skills: oral, written and listening</li> <li>Ability to influence without authority across cross-functional organization</li> </ul> U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $111,000 to $134,400 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Specialist I, Quality Assurance

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. JOB SUMMARY The Senior BioProcess Engineer will provide technical leadership on major development-, manufacturing-, and tech transfer-related projects. The incumbent will plan, coordinate, communicate, and summarize projects. The incumbent should have solid education, technical and organizational leadership, and proven development and CGMP experience to support MS&T mission, i.e., to ensure that manufacturing processes are capable, compliant, in control, cost-effective, and continuously improved. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. The MSAT department at the Canton site of Emergent BioSolutions ensures that manufacturing processes are capable, compliant, in control, cost-effective, and continuously improved. Our core responsibilities include: <ul> <li> Enable reliable supply of vaccines and therapeutics by providing direct scientific and technical leadership to commercial manufacturing operations. </li> <li> Anticipate, respond to, and permanently resolve manufacturing issues to safeguard our right to operate and supply. </li> <li> Support new processes, equipment, facility design, and other life-cycle activities to improve quality, efficiency, capacity, and economics. </li> </ul> Business <ul> <li> Work independently with little to no supervision. Exercise considerable latitude in determining technical objectives/approaches to major assignments. </li> <li> System owner responsibilities for multiple focus areas within the MS&T function, e.g., Process Monitoring, Process Validation, Technology Transfer, Continued Process Verification, etc. </li> <li> Maintain good working relationships with internal and external partners/customers, i.e., Manufacturing, QA, QC, Regulatory, Engineering, Supply Chain, EHS, etc. </li> <li> Guides the successful completion of major programs and may function in a project leadership role. </li> <li> Participate on MS&T Leadership Team to ensure appropriate alignment of resources to technical challenges and routine operational needs. </li> </ul> Technical <ul> <li> Provide fast-paced campaign support for manufacturing during technical production issues or escalations. </li> <li> Represent MS&T as the prime technical contact on contracts and projects. </li> <li> Work with manufacturing teams to provide technical support to develop platform procedures, batch records, training, and other manufacturing resources as required to prepare for and execute processes. </li> <li> Support existing business processes such as reviewing and approving MFG SOP/FRM/BPR document revisions, deviations, CAPAs, CCRs. </li> <li> Develop and maintain structure for process data reviews for internal and external production. </li> <li> Develop and draft study plans and protocols as required to support process changes, deviation responses, and regulatory requirements, etc. </li> <li> Lead process investigations and drive process improvement initiatives. </li> <li> Review technical documents authored by the other team members. </li> <li> Evaluate and develop advanced technological ideas and summarize their development into final reports. </li> </ul> Scientific <ul> <li> Designs experiments for the development of cell lines and optimization of cell line production processes; analyzes the data from such experiments and participates in the formulation of conclusions and next steps. </li> <li> Serves as lead for tech transfer of cell culture and purification processes to internal departments. </li> <li> Develops and maintains cell lines and cell banks </li> <li> Writes and executes experimental protocols for developing/optimizing processes for potential use in manufacturing. </li> <li> Trouble-shoots and maintains cell culture and purification systems. </li> <li> Trains other members of the team in techniques. </li> <li> Safely handle serum and/or tissues from preclinical studies as well as samples of human origin. </li> <li> Safely handles BSL-2 reporter viruses and tissue samples under a BSC. </li> </ul> People Management/Employee Development <ul> <li> Supervise daily activities for Intern/Co-op students and contractors to ensure safety and effectiveness </li> <li> Assist Manager in bringing new staff up to speed. Train new employees or junior staff on hands-on skills </li> <li> Mentor junior staff on technical and operational skills </li> </ul> The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. MINIMUM EDUCATION, EXPERIENCE, SKILLS Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws. <ul> <li> BS, MS, or PhD in Science or Engineering with a minimum of (BS+8yrs) /(MS+6yrs)/ (PhD+4yrs) of relevant job experience in biopharma or pharmaceutical industry </li> <li> The Senior BioProcess Engineer should have solid technical leadership in several functional areas and in-depth CGMP experience with vaccines/biologics manufacturing science and technology. </li> <li> Experience working under a Quality Management System. </li> <li> Ability to manage multiple priorities and tasks in a dynamic environment. Ability to make sound scientific decisions regarding compliance-related issues with minimal supervision and guidance. </li> <li> Work effectively in a team environment and have a high level of personal accountability and responsibility. </li> <li> Personal Competencies: Self-awareness, Integrity, Team Player, Adaptability </li> <li> Understanding of MS&T activities including but not limited to: Technology Transfer Strategy and Implementation; Process Development, Product Process Improvement, QbD / PAT; Process Characterization and Control; Process validation </li> <li> Comprehensive technical knowledge with a strong science-and-risk based mindset </li> <li> An understanding of scientific methods, statistical analysis, and standard lab notebook format. </li> <li> Robust technical and communication skills: oral/written and listening </li> <li> Proficient in Microsoft Office and statistical and productivity software, i.e., JMP/MiniTab or equivalent, Visio, MS Project, etc. </li> </ul> Preferred Qualifications <ul> <li> Good organization skills; high-level personal accountability and responsibility; proven planning, organization, and multitasking skills </li> <li> Stay abreast of emerging technology, digital transformation, and industry trends </li> <li> Direct experience in tech transfer, engineering, quality, and regulatory </li> <li> Expertise with all aspects of project management skills, including planning, tracking, adhering to budget/schedule and communicating, etc. </li> <li> Good understanding of drug product processes </li> <li> Hands-on experience with high throughput bioreactor systems. </li> <li> Capable of searching scientific literature to gain information about specific topics. </li> </ul> U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $129,000 - $156,000. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Sr BioProcess Engineer, MS&T

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. JOB SUMMARY The primary role of this position is to partner with department managers to plan, procure and source materials, equipment and services for a multi-product manufacturing facility of bulk vaccine, as well as serve as the bridge between internal and external business partners to ensure the timely and cost-effective delivery of high quality goods and services. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.<ul> <li>Work with department managers to identify and recommend suppliers for capital equipment and facility services to develop budgetary quotes and bid packages. Analyze bids and suppliers' operations to determine factors that affect prices and determine most economic cost consistent with quality and delivery requirements.</li> <li>Provide leadership, direction, and development to other department staff.</li> <li>Facilitate contract request process with end user and legal departments. negotiate, create, and manage contracts with key suppliers as applicable.</li> <li>Support company goals by developing and improving procurement methods while safeguarding and improving the integrity of the procurement process.</li> <li>Negotiate the terms and pricing on the procurement of goods and services. Prepare reports by collecting, analyzing, and summarizing information and trends.</li> <li>Source raw materials, reagents, media, standard supply and lab supplies.</li> <li>Create and manage purchase orders for inventory, capital equipment, services and general supplies.</li> <li>Support the development of purchasing specifications by analyzing technical data and company requirements.</li> <li>Conduct cost analysis on the comparison of various materials and services for initial or continued procurement.</li> <li>Serve as a liaison between the company and supplier to address requirements, non-conformance, delivery and invoice issues.</li> <li>Assist audit department with performing supplier quality audits as needed.</li> <li>Develop supplier consolidation, cost reduction, and inventory reduction programs.</li> <li>Conduct annual review with key suppliers - review supplier reliability, risk mitigation, financial stability, capacity, etc.</li> <li>Assist finance department with Sarbanes-Oxley audits, along with other various agencies audits.</li> <li>Process change controls and deviations as required.</li> <li>Oversight of supplier data integrity in SAP.</li> <li>Create / revise departmental standard operating procedures.</li> <li>Assignment to departmental / company projects as required.</li> </ul>The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS<ul> <li>Bachelors' degree in Business, or another supply chain related field.</li> <li>5 - 7 years of procurement experience preferably within the biopharmaceutical industry.</li> <li>Previous people manager experience preferred.</li> <li>Excellent Communication skills both written and verbal.</li> <li>Excellent Analytical skills required.</li> <li>Must be detail oriented.</li> <li>SAP experience preferred.</li> </ul> If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled. U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $129,000 to $151,500 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

Sr Buyer

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. JOB SUMMARY The Senior Automation Engineer is the site-level technical authority and owner for all aspects of automation, control systems, and computerized systems at the Canton, MA GMP Vaccine Drug Substance manufacturing site. This role is accountable for ensuring the reliability, compliance, lifecycle management, and continuous improvement of process, utility, and facility automation systems supporting commercial and clinical vaccine manufacturing. The position requires deep hands-on expertise with GMP automation in biologics/vaccine environments and close collaboration with Manufacturing, MSAT, Quality, Validation, Facilities, and Capital Projects teams. The Senior Automation Engineer will lead automation strategy, support deviation investigations and CAPAs, enable process improvements, support technology transfer activities, and serve as the primary subject matter expert (SME) during internal and external regulatory inspections. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.<ul> <li>Serve as the automation system owner for the Canton site, with end-to-end responsibility for process control, PLC/DCS, SCADA, HMI, Batch systems, Building Management Systems (BMS), historians, and associated infrastructure throughout their lifecycle (design through retirement).</li> <li>Ensure all automation systems remain in a validated state in compliance with GMP, GAMP 5, 21 CFR Parts 210, 211, and Part 11 requirements, including authoring, reviewing, and approving system lifecycle documentation (URS, FRS, DDS, risk assessments, commissioning and qualification protocols, reports).</li> <li>Provide technical leadership for troubleshooting complex automation, control, and integration issues impacting manufacturing operations, utilities, and facilities; support manufacturing in real-time to minimize downtime and ensure product supply.</li> <li>Lead and support deviation investigations, root cause analysis, and CAPA implementation related to automation and computerized systems.</li> <li>Drive continuous improvement and process optimization initiatives through automation enhancements, risk reduction, standardization, and modernization of legacy systems.</li> <li>Actively support process improvement, MSAT, and technology transfer efforts by ensuring automation readiness, scalability, data integrity, and alignment with new or modified manufacturing processes.</li> <li>Manage and oversee automation activities for capital projects, including scope development, vendor selection, design review, integration, commissioning, qualification, and handover to operations.</li> <li>Develop and maintain site automation standards, procedures, SOPs, PMs, and engineering best practices; provide training to operations, engineering, and maintenance personnel as required.</li> <li>Coordinate and manage external system integrators, vendors, consultants, and contractors to ensure delivery meets safety, quality, schedule, and budget expectations.</li> <li>Serve as the site automation SME during audits, inspections, and regulatory interactions, including direct engagement with regulatory agencies as required.</li> <li>Partner closely with Quality, Validation, IT, and Engineering to support change control, data integrity, cybersecurity, and inspection readiness activities.</li> <li>Provide technical mentorship and guidance to other engineers and technicians, contributing to capability building and knowledge retention at the site.</li> </ul>The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS<ul> <li> Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.Bachelor's degree in Electrical, Chemical, Mechanical, Biochemical Engineering, or a related engineering discipline; advanced degree preferred. </li> <li>Minimum of 8 years of progressive automation engineering experience within a GMP-regulated pharmaceutical, biologics, or vaccine manufacturing environment; direct Drug Substance (DS) and/or vaccine experience strongly preferred.</li> <li>Demonstrated expertise in GMP automation, computer system validation (CSV), and commissioning and qualification of manufacturing systems.</li> <li>Strong knowledge of regulatory and industry standards including GMP, GAMP 5, FDA 21 CFR Parts 210/211, Part 11, and data integrity principles.</li> <li>Hands-on experience programming, configuring, and troubleshooting PLCs and HMIs (Allen-Bradley/Rockwell preferred), SCADA systems, batch control platforms, and process instrumentation.</li> <li>Proven experience with Building Management Systems (BMS), process historians, and integration of automation systems across manufacturing, utilities, and facilities.</li> <li>Experience with change management systems, deviation management, CAPAs, and quality systems within regulated environments.</li> <li>Familiarity with ERP/CMMS platforms (e.g., SAP) for work orders, calibration, and maintenance management.</li> <li>Proven ability to work cross-functionally, communicate effectively with technical and non-technical stakeholders, and lead complex technical discussions.</li> <li>Strong analytical, problem-solving, and decision-making skills with the ability to prioritize in a fast-paced manufacturing environment.</li> </ul>**This position is relocation eligible within the United States** If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled. U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $150,000 to $176,000 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

Sr Engineer, Automation

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. The Sr Engineer, Process is a key technical leader supporting GMP vaccine drug substance manufacturing operations. This role provides hands-on process engineering support to ensure safe, reliable, and compliant manufacturing across upstream and downstream operations. The Senior Process Engineer is accountable for real-time troubleshooting of process and equipment issues on the manufacturing floor, driving rapid root cause identification and sustainable solutions while maintaining uninterrupted GMP operations. This position partners closely with Manufacturing, MS&T, Quality, Automation, and Facilities to support commercial manufacturing, technology transfers, process optimization, deviation investigations, and change management. The role also provides engineering ownership across the process lifecycle, including process design, scale-up, equipment specification, commissioning, qualification, and continued process verification in compliance with FDA, EMA, and global regulatory expectations ESSENTIAL FUNCTIONS &bull; Provide direct, real-time process engineering support on the manufacturing floor for GMP vaccine drug substance operations, including upstream, downstream, and process support systems. &bull; Lead and execute troubleshooting of process and equipment deviations, collaborating with cross-functional teams to identify root causes and implement effective CAPAs. &bull; Serve as process owner and subject matter expert (SME) for assigned unit operations and manufacturing systems, ensuring robust and compliant operation. &bull; Support and lead process improvements, optimization initiatives, and capacity enhancements using data-driven and risk-based approaches. &bull; Author, review, and approve GMP documentation including deviations, change controls, process risk assessments, protocols, reports, and regulatory-facing technical documentation. &bull; Support technology transfer activities, including process characterization, equipment fit assessments, and operational readiness for new or modified processes. &bull; Lead or execute commissioning, qualification, and validation activities for process equipment and systems, including support of FATs, SATs, and PPQ. &bull; Partner with Quality Assurance to ensure alignment with Quality Systems, data integrity requirements, and regulatory commitments. &bull; Provide technical input during regulatory inspections and audits and present process and equipment information as a subject matter expert. &bull; Collaborate with vendors, contractors, and internal engineering groups to support equipment reliability, lifecycle management, and continuous improvement. &bull; Mentor junior engineers and contribute to engineering standards, best practices, and knowledge sharing across the site. MINIMUM EDUCATION, EXPERIENCE, SKILLS Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws. &bull; Bachelor's degree in Chemical, Biochemical, Mechanical, or related Engineering discipline; advanced degree preferred. &bull; Minimum of 7-10 years of progressive process engineering experience in GMP-regulated biopharmaceutical or vaccine drug substance manufacturing. &bull; Demonstrated hands-on experience supporting manufacturing operations, including real-time troubleshooting and floor support in a GMP environment. &bull; Strong working knowledge of vaccine or biologics unit operations, including upstream processing, downstream purification, formulation, CIP/SIP, and single-use technologies. &bull; In-depth understanding of GMP regulations, validation lifecycle, change management, deviation management, and data integrity principles. &bull; Proven experience with process design and engineering documentation such as PFDs, P&IDs, URS, FMEA, and equipment specifications. &bull; Ability to apply engineering fundamentals to complex manufacturing problems using structured root cause and risk management tools. &bull; Effective communicator with the ability to interface with Manufacturing, Quality, Regulatory, and senior leadership. &bull; Proficiency with common engineering and enterprise systems (e.g., AutoCAD, MS Office, electronic quality systems, SAP preferred). &bull; Ability to work in a fast-paced manufacturing environment and provide on-call or off-shift support as needed to ensure uninterrupted operations. U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $129,000 to $156,000 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Sr Engineer, Process

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. Job Summary The Sr. Engineer, Validation ensures cGMP regulatory compliance through adherence to site and corporate validation Plans, Policies, and Procedures. This position supports ensuring accountability and oversight within the validation program, validation projects, and leads innovation. Sr Engineer, Validation will independently work on multi-faceted projects (Capital, Client and Overhead), manage multiple tasks/priorities. Core competencies for this position are Collaborates, Communicates Effectively, Directs Work, Ensures Accountability and Customer Focus. This position provides Subject Matter Expertise (SME) and oversight in multiple disciplines owned by the validation department. These disciplines are; Commissioning and Qualification, Computer Systems Validation, Validation Maintenance/Risk Management, and Laboratory Systems Validation. The Sr. Engineer, Validation performs with a high degree of autonomy and represents the department on interdisciplinary teams. This position leads by example, achieves solutions to complex problems, serves as a technical expert, communicates effectively, collaborates and bridges GAPs. The Sr. Engineer, Validation supports engineering, quality, manufacturing sciences and technology, and manufacturing by providing SME support and accountability within the Validation department. The Sr. Engineer, Validation will also be responsible for providing leadership and technical guidance to the team aimed at implementing best practices and improving the overall performance of the team. Essential Functions Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Technical Expertise<ul> <li>Create and execute commissioning, qualification protocols, and validation protocols and plans (CX/IQ/OQ/PQ), including identificationand resolution of non-conformances consistent with site procedures and practices.</li> <li>Provide equipment, system and facility commissioning and qualification guidance and strategy execution during project planning and development phases.</li> <li>Reviews and approve technical documentation including system lifecycle design documentation (user requirements, functional and design specifications, commissioning and qualification protocols).</li> <li>Perform equipment, aseptic processing, steam sterilization and process validation and their associated control systems.</li> <li>Review and approve department deliverables (protocols and quality systems) Perform investigations and implement corrective actions related to CAPAs and deviations.</li> <li>Developing broader skills personally by applying this knowledge to work assignments and departmentally through resource and program development.</li> <li>Plan, Coordinate, and Execute assigned projects by effectively using Project Management methodologies.</li> <li>Participate in regulatory inspection and response activities.</li> <li>Represents validation on internal teams, committees and at technical conferences.</li> <li>Report status and progress of qualification activities or projects to the Leadership team.</li> </ul>Leadership Skills<ul> <li>Owns assigned Validation Plans, Procedures and Projects supporting program compliance.</li> <li>Manage and directs work for assigned projects ensuring activities are on time, within budget, meet GxP and company requirements.</li> <li>Possesses strong knowledge of current validation best practices, including governmental regulations and GxPs.</li> <li>Demonstrated success in technical proficiency, creativity and collaboration with others through independent thought, communication and technical writing.</li> <li>Provide customer focus supporting engineering, quality, manufacturing sciences and technology, and manufacturing as a Subject Matter Expert within the Validation department.</li> </ul>Problem Solving<ul> <li>Proposes unique solutions to complex problems using technical proficiency, creativity and collaboration with others through independent thought, communication and technical writing.</li> <li>Supports and owns process troubleshooting, operations support, root cause analysis, and risk assessment.</li> <li>Uses proven monitoring and problem-solving techniques such as SPC and DMAIC.</li> <li>Exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.</li> <li>Determine methods and procedures on complex assignments and implement them after obtaining necessary stakeholder approvals.</li> <li>Determining methods and procedures on complex assignments and providing technical direction and guidance to engineers within the Validation department.</li> <li>Demonstrate strong leadership and management qualities when working within the department and other stakeholder groups that yield results.</li> </ul>The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. Minimum Education, Experience & Skills Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.<ul> <li>BS Engineering/Chemistry/Microbiology or related field and/or a Minimum 8 years related industrial experience in system qualification or validation.</li> <li>Expert knowledge of validation principles and concepts.</li> <li>Demonstrated ability to use and operate independently within software common to Validation Departments: Microsoft (Word, Excel, Power Point), Kaye AVS.</li> <li>Possesses strong knowledge of engineering and related practices, including governmental regulations - ISPE, EU, CFR 210, 211, Part 11.</li> <li>Experience with systems such as CIP, SIP, Autoclaves, Temperature Controlled Units, Critical Utilities, Facilities, Equipment systems, Computer or Controls Systems preferably used in a GMP environment.</li> <li>Read and interpret drawings such as PFDs, P&IDs and electrical schematics. Strong communication and computer skills.</li> <li>Demonstrates success in technical proficiency, creativity, and collaboration with others and independent thought.</li> <li>Makes decisions exercising judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Ensure alignment and communication of issues and strategies.</li> <li>Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities and business needs.</li> </ul>U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $129,000 to $156,000. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Sr Engineer, Validation

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. JOB SUMMARY The Senior Manager, Quality Assurance Operations provides senior leadership and oversight of GMP Quality Assurance Operations at a vaccine Drug Substance manufacturing site, ensuring compliant execution of manufacturing activities and effective implementation of site quality systems in alignment with Site Quality Management expectations and global Quality standards. This role is accountable for real time QA oversight of manufacturing operations, lifecycle management of deviations, CAPAs, change controls, validation activities, and risk management, while operating as a key Quality decision-maker independent of Production, consistent with CGMP requirements. The position partners closely with QA Compliance and Supplier Quality, Quality Control, and Site Quality Management to ensure effective inspection readiness, audit support, risk escalation, and Quality Management Review (QMR) execution. The Sr. Manager supports internal and external projects, including technical transfers, supplier and partner interactions, and network initiatives, and is expected to cross train within the Quality Unit to ensure continuity of critical quality responsibilities. This role directly contributes to sustaining a state of control, regulatory confidence, and a strong quality culture across site operations. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Quality Operations Oversight<ul> <li>Provide senior QA oversight for GMP manufacturing operations, ensuring controls are implemented and executed in accordance with approved procedures and regulatory requirements.</li> <li>Maintain robust QA presence on the floor, supporting real time decision making, logbook review, batch documentation review, and issue resolution.</li> <li>Ensure Quality remains independent of production while enabling compliant execution.</li> </ul>Quality Systems Execution<ul> <li>Lead and oversee Deviations, CAPAs, Change Controls, Effectiveness Checks, and other site quality systems in accordance with SOP040945 and global procedures.</li> <li>Ensure timely, high quality investigations using sound root cause analysis and risk-based decision making.</li> <li>Review and approve complex investigations, including manufacturing deviations, OOS/OOT events, and excursions.</li> </ul>Risk Management & State of Control<ul> <li>Apply Quality Risk Management (ICH Q9) principles to assess, escalate, and mitigate quality and compliance risks.</li> <li>Support site and corporate Quality Risk assessments and ensure alignment with Site Quality Management expectations.</li> <li>Identify adverse trends and partner with QA Compliance to ensure appropriate escalation to senior management.</li> </ul>Validation & Lifecycle Oversight<ul> <li>Provide QA oversight and approval for qualification and validation protocols, reports, and deviations for facilities, utilities, equipment, processes, QC methods, and computerized systems.</li> <li>Ensure validation activities align with regulatory expectations and site control strategy.</li> </ul>Inspection Readiness & Audit Support<ul> <li>Support internal audits and regulatory inspections by ensuring QA Operations processes, records, and personnel are inspection ready.</li> <li>Participate as a Subject Matter Expert during regulatory inspections and audits, supporting responses and remediation activities in partnership with QA Compliance.</li> <li>Ensure operational readiness for FDA (CBER), global health authorities, and partner audits.</li> </ul>Quality Metrics & Management Review<ul> <li>Develop, trend, and present Key Performance Indicators (KPIs) supporting Quality Management Review (QMR).</li> <li>Provide operational quality insights to support assessment of process performance, product quality trends, and state of control.</li> <li>Communicate quality performance to site and corporate Quality leadership.</li> </ul>People Leadership & Organizational Resilience<ul> <li>Lead, coach, and develop QA Operations personnel, ensuring proper training, qualification, and performance management.</li> <li>Promote cross-training within the Quality Unit to support continuity of quality responsibilities.</li> <li>Foster a culture of accountability, engagement, and continuous improvement.</li> </ul>Projects, Technology Transfer & Partnerships<ul> <li>Provide QA Operations leadership for technology transfer activities, lifecycle changes, and introduction of new or modified processes.</li> <li>Support internal and external partnerships by ensuring Quality requirements are integrated into execution and risk is appropriately managed.</li> <li>Collaborate with Supplier Quality and Compliance functions to ensure operational impacts from supplier or partner activities are properly assessed.</li> </ul>The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws. Education<ul> <li>Bachelor's degree in Biological Sciences, Chemistry, Engineering, or a related scientific discipline required.</li> <li>Advanced degree preferred.</li> </ul>Experience<ul> <li>8-10+ years of progressive GMP Quality experience within pharmaceutical or biotechnology manufacturing.</li> <li>Demonstrated experience supporting biologics or vaccine Drug Substance operations.</li> <li>Proven leadership of QA Operations and Quality Systems in a regulated manufacturing environment.</li> <li>Prior experience supporting regulatory inspections, internal audits, and inspection readiness activities.</li> <li>Experience supporting technical transfers, validation activities, and cross functional quality initiatives.</li> <li>Previous people leadership experience is required.</li> </ul>Skills & Competencies<ul> <li>Strong working knowledge of CGMP regulations, industry guidance (FDA, EMA, ICH), and phase-appropriate quality expectations.</li> <li>Demonstrated ability to assess risk, interpret complex data, and make sound quality decisions in a fast-paced manufacturing environment.</li> <li>Excellent written and verbal communication skills, including the ability to present complex quality topics to senior leadership.</li> <li>Influential leader capable of operating effectively in a cross-functional, matrixed organization.</li> <li>Ability to critically review and approve SOPs, validation documents, investigations, protocols, and regulatory responses.</li> <li>Strong organizational skills with the ability to manage multiple priorities simultaneously.</li> <li>Proficiency with MS Office applications (Word, Excel, PowerPoint) and electronic quality management systems (eQMS).</li> </ul> U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $171,500 to $207,500 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Sr Manager, QA Operations

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. JOB SUMMARY The Sr. Manager, Training is a senior Quality leadership role accountable for the end-to-end governance, effectiveness, and continuous improvement of the GMP Training program at the Canton, MA GMP vaccine Drug Substance (DS) manufacturing site. The role ensures site compliance with applicable U.S. and international GxP regulations, Emergent Global Quality Standards, and regulatory expectations (e.g., FDA, EMA). This position serves as the site owner for the Learning Management System (LMS/eLM), with direct responsibility for training program strategy, inspection readiness, and data integrity. The incumbent partners closely with Global Process Owners (GPOs) for Training and related Quality systems to ensure consistent global-to-site deployment, effective implementation of system upgrades, and alignment with evolving regulatory and business needs. The Sr. Manager acts as a key Quality representative for internal and external audits, and supports site leadership by providing actionable KPIs, risk-based insights, and strategic recommendations to sustain a Compliant, inspection-ready, and agile Quality system. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.<ul> <li>Own, manage, and continuously improve the site GMP Training Program in alignment with regulatory expectations, Global Standards, and site operations.</li> <li>Serve as Site Process Owner (SPO) for LMS/eLM, including system configuration, administration, governance, change management, user access, and data integrity oversight.</li> <li>Ensure periodic GMP training, role-based qualification, and personnel competency programs are implemented, maintained, and inspection-ready in accordance with CGMP and internal procedures.</li> <li>Approve GMP training materials and ensure training content is technically accurate, risk-based, and appropriate for adult learners, including instructor-led training, OJT, and electronic learning.</li> <li>Partner with Global Process Owners (GPOs) to deploy global processes, system enhancements, integrations, and performance metrics at the site while managing site-specific impacts and regulatory risks.</li> <li>Establish, monitor, and report meaningful KPIs and effectiveness metrics for training compliance, qualification status, document lifecycle performance, and inspection readiness.</li> <li>Lead gap assessments, root cause evaluations, and CAPAs related to training; ensure timely and sustainable remediation.</li> <li>Ensure job descriptions, curricula, qualifications, and CVs are maintained within employee electronic training records in compliance with regulatory and internal requirements.</li> <li>Act as a primary Quality contact for client, internal, and regulatory inspections impacting training systems; participate in inspection preparation, execution, response, and follow-up.</li> <li>Drive continuous improvement initiatives leveraging risk management principles (ICH Q9) and Quality system maturity concepts (ICH Q10).</li> <li>Build organizational capability through mentoring, technical development, and cross-functional collaboration.</li> <li>Proactively identify resource needs and advocate for investments required to sustain compliant and scalable systems.</li> <li>Partner with site and Quality leadership to embed Quality culture, accountability, and compliance into daily operations.</li> </ul>The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS Education:<ul> <li>Bachelor's degree in Life Sciences, Education, Engineering, or a related scientific discipline required.</li> <li>Master's degree or advanced certification in Quality, Regulatory, Instructional Design, or Business Management preferred.</li> </ul>Experience:<ul> <li>Minimum of 8-10 years of experience in a regulated biopharmaceutical, vaccine, or biotechnology manufacturing environment with direct GMP accountability.</li> <li>Minimum of 5 years of progressive experience in GMP Training or Quality Systems</li> <li>Demonstrated experience administering and governing LMS/eLM platforms in a GMP environment.</li> <li>Proven experience supporting regulatory inspections (e.g., FDA, EMA) and managing inspection outcomes, including responses and remediation.</li> <li>Experience partnering with global organizations and Global Process Owners to implement enterprise Quality systems and standards.</li> </ul>Technical Skills and Competencies:<ul> <li>Expert knowledge of U.S. and international GMP regulations, GDocP, and Quality Systems (21 CFR Parts 210/211, ICH Q7, Q9, Q10).</li> <li>Strong understanding of GMP training principles, competency-based qualification, adult learning theory, and instructional design.</li> <li>Strong analytical skills with the ability to interpret metrics, identify trends, and drive risk-based decisions.</li> <li>Excellent written and verbal communication skills, with the ability to communicate effectively at all organizational levels, including senior leadership and regulators.</li> <li>Proven leadership, influencing, and change management skills with a track record of fostering collaboration across Quality, Manufacturing, MSAT, and Engineering.</li> <li>High level of personal integrity, sound judgment, accountability, and commitment to quality culture.</li> </ul> If the hiring manager expresses an interest in interviewing you for the open position, you must discuss your interest in the open position with your current manager prior to an interview being scheduled. U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $150,000 to $181,500 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

Sr Manager, Training

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. JOB SUMMARY The Sr. Production Maintenance Technician is a skilled position responsible for both predictive and preventive maintenance of all equipment on a diverse range of systems. This includes fermenters, centrifuges, CIP and piping systems, autoclaves and other machinery common in the pharmaceutical/biopharmaceutical industry. Experience and knowledgeable maintenance technician that can work in a controlled environment that has closed space and cleanliness requirements. This includes not only the physical and skilled aspects to the job, but also planning and communicating work, working with software systems to document work performed according to Good Documentation Practice (GDP). ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.<ul> <li>Takes initiative and works independently on complex assignments.</li> <li>Able to confidently act as facilitator, trainer and team leader on multiperson repairs and projects. </li> <li>Fully understands work and provides solutions and recommendations in resolving issues.</li> <li>Provide technical and mechanical support on all GMP and Non-GMP utility systems.</li> <li>Performs routine Preventive Maintenance (PM) on equipment and systems.</li> <li>Execute work orders and document work performed in SAP per Good Documentation Practice (GDP).</li> <li>Maintain process control equipment and control loop systems, as well as prepare preventative maintenance documentation and SOPs within cGMP requirements.</li> <li>Respond to emergency and alarm conditions and be on-call per scheduled times for emergency service calls and must respond to the site to repair/address issues. </li> <li>Support campus landscaping, snow removal, pest control systems to ensure safe and excellent site. </li> <li>Supports other maintenance disciplines as needed. </li> <li>Maintain a professional, courteous, respectful relationship with internal customers.</li> <li>Seek ways to increase operational efficiency and reliability as continuous improvements to all processes.</li> <li>Participate in 6-S initiatives for Facilities Department and facilitates weekly walk through of buildings, mechanical rooms, and grounds to assure all areas of the site are clean and audit ready every day.</li> </ul>The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. MINIMUM EDUCATION, EXPERIENCE, SKILLS<ul> <li>Minimum of 6-years or greater experience in maintenance</li> <li>2-year trades vocational certificaiton or equivalent experience</li> <li>The employee must have the ability to work rotating twelve hour shifts on a rotating day basis</li> <li>Working knowledge of the following maintenance functions: <ul> <li>General Mechanical Troubleshooting / Repairs</li> <li>Critical Utilities <ul> <li>Water for Injection and Pre-treatment Systems</li> <li>Clean Steam Generators</li> <li>Clean Compressed Gas Systems</li> <li>Reverse Osmosis Water Systems</li> <li>Water Softening Processing Equipment</li> <li>Passivation Processes</li> </ul> </li> <li>Production Support Equipment <ul> <li>Fermenters</li> <li>Autoclaves</li> <li>Parts Washers</li> </ul> </li> </ul> </li> <li>Must have aptitude for computer systems including maintenance documentation, email, word, excel, building automation operations</li> <li>Prior cGMP regulated industry experience is strongly preferred</li> <li>Must have the ability to multi-task and coordinate workload by priority</li> <li>Must be customer service and quality driven </li> </ul> U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from $73,000 to $88,300 . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Sr Production Maintenance Technician

Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. I. JOB SUMMARY Emergent is looking for a Senior Counsel - Commercial to join its growing Legal team. The position is an exciting opportunity to join a fast-paced, dynamic legal department supporting all aspects of the commercial organization. The successful candidate will provide legal support for a breadth of complex US and global legal, regulatory and compliance matters by providing practical, timely, strategic, and high-quality legal advice to a broad spectrum of clients across the organization. Focus is on counseling regarding risks related to Federal Trade Commission (FTC) guidance, fraud and abuse, anti-kickback, US Food and Drug Administration (FDA), Office of Inspector General (OIG) guidance, product liability issues, privacy, reputational risk, and various state and federal laws (e.g., False Claims Act, Sunshine Act, CAN-SPM, TCPA, etc.) II. ESSENTIAL FUNCTIONS Reasonable accommodation will be made to enable individuals with disabilities to perform essential functions.<ul> <li>Provide solutions-oriented legal advice in the promotional review of marketing, sales, medical, and training assets in conjunction with regulatory and medical partners.</li> <li>Provide strategic legal advice and proactive solutions to commercial business teams.</li> <li>Provide legal support to Company business units advising internal stakeholders on compliance with applicable federal and state healthcare laws, regulations and industry standards (e.g., FDCA, AKS, PhRMA Code).</li> <li>Provide advice on internal and external communications by non-marketing and sales functions.</li> <li>Provide practical and timely legal guidance on issues related to sales and marketing, market access, patient advocacy, patient services, medical information, fee-for-service arrangements, drug pricing, data privacy initiatives, social media, use of endorsers and/or celebrities, drug labeling, strategic plans and tactics, competitive issues, and interactions with nonprofits. </li> <li>Support Government Affairs and coordinate with external counsel on GA matters when needed.</li> <li>Represent Legal on various cross-functional committees and teams.</li> <li>Collaborate with legal, regulatory, and compliance colleagues in providing guidance and input on a broad range of complex agreements.</li> <li>Provide support for regulatory, medical affairs and product development teams, including legal interpretation of laws, regulations, and guidance documents related to the development and commercialization of pharmaceutical and biopharmaceutical products.</li> <li>Provide education and training of business and cross functional stakeholders on commercial best practices and policies.</li> <li>Actively participate in department initiatives, identifying opportunities to enhance the effectiveness of Legal department operations.</li> <li>Assist with internal policies, training, and corporate governance initiatives</li> <li>Participate in business development activities (merger and acquisitions, licensing and other partnering opportunities), including deal and risk assessment and due diligence</li> <li>Other duties as assigned The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. </li> </ul>III. MINIMUM EDUCATION, EXPERIENCE, SKILLS<ul> <li>Law Degree from an ABA accredited school and licensed and in good standing in at least one U.S. State</li> <li>Licensed to practice law in at least one state and in good standing</li> <li>A minimum of 5-7 years of experience working in a law firm and/or pharmaceutical or biotechnology legal department, with at least 2+ years' in-house experience in the biotech and/or pharmaceutical industry</li> <li>Understanding of the legal issues affecting the pharmaceutical industry, including regulatory processes and guidance for prescription and OTC drugs, anti-kickback, fraud and abuse, anti-bribery and anti-corruption and antitrust laws. Working knowledge of the global regulatory environment. In-depth understanding of the pharmaceutical industry, including IP, manufacturing, R&D, regulatory, and commercial elements.</li> <li>Strong ability to grasp legal issues quickly, exhibit strong analytical problem solving and decision-making skills, exercise sound judgment, and provide practical and constructive legal advice in a time-sensitive, dynamic, and fast-paced complex environment.</li> <li>Strong negotiation and communication skills (both oral and written). Ability to communicate legal issues in a clear and understandable manner. Builds relationships across functions and sites and inspires trust and confidence through effective communication and interpersonal skills. Experience working in a matrix environment is a plus.</li> <li>Ability to work independently and take initiative to drive forward priorities, complete tasks and appropriately manage risks.</li> <li>Strong work ethic and ability to manage large workload, focus on critical priorities, and otherwise effectively meet client needs directly and with members of the Legal, Regulatory and Compliance teams</li> <li>Strong oral, written and presentation skills and ability to clearly articulate complex information</li> <li>Strong analytical and problem-solving skills, with attention to detail</li> <li>Ability to establish and maintain effective working relationships throughout the organization</li> <li>Experience supporting products ex-US highly desirable</li> </ul> U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from [ $206,500 to $250,000] . Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

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