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Job Description GENERAL SUMMARY : The Sustainability & Utility Engineer is a member of the Plant Engineering team providing direct hands on technical support to the Durham Site. The site includes an Energy Center, Vaccines DP and DS Manufacturing Facilities, Quality Labs, various other manufacturing buildings and Maintenance and Material Storage Facility (MMSF). This support position will focus on leading investigation of Electrical system excursions, engineering maintenance, design system improvements and optimizations and hands on troubleshooting. This individual will provide input to the deviation investigation process for determination of root cause, recommend corrective actions to prevent re-occurrence and help assess the impact on operations. The incumbent will also be responsible for leading plant engineering's sustainability improvement projects and implementation of productivity enhancement initiatives. GENERAL PROFILE: <ul><li> Individual contributor role working with professional employees and/or contractors. </li><li> Contributes to the performance and results of the department. </li><li> Manage the Durham Site's Sustainability portfolio in its entirety involving any of the following: </li><li> Regulatory compliance with internal interpretations </li><li> Manage project strategy for the Durham Site to achieve Net Zero goals based on sustainability Mater Plan </li><li> Develop Business case for sustainability projects to ensure appropriate return in financial and emissions reductions. Determine execution strategy for each </li><li> Develop project execution plan for main components all requirements of the program involving above site commitments and site level commitments. </li><li> Perform ongoing monitoring of systems and ensure returns are being achieved. </li><li> Report on and run governance meetings to manage the program, solicit help and ensure targets are met. </li><li> Execute tasks within the program to achieve plan developed. </li><li> Work with third party vendors and engineering firms to assist in development and completion of any tasks related to program support. </li><li> Perform other maintenance and departmental tasks as required for success like maintenance plan updates, SOP/SBP draft and updating, drawing support, etc </li><li> Adapts departmental plans and priorities to address resource and operational challenges. </li><li> Decisions are guided by policies, procedures and business plan; receives guidance from manager. </li><li> Provides technical guidance to employees, colleagues or contractors </li><li> Anticipates and interprets client and/or customer needs to identify solutions </li><li> Works as a liaison between Plant Engineering and other Site Business Partner's </li><li> Team member for small capital projects for plant engineering </li><li> Obtains bids, reviews contracts, supervises, and follows-up on contract work including. </li><li> Actively Participates in and contributes to shutdown schedule including all maintenance, calibration, capital project work, and GMP Cleaning for all facility shutdowns </li><li> Coordinates with Site Engineering and IPT production planners </li><li> Attends daily shutdown meetings ensuring owned activities are tracked and completed </li><li> Participate in cross-functional teams for engineering Operations projects, or other plant activities as needed. </li><li> Works to streamline and improve Maintenance department systems, procedures and ways of working with a focus on safety, current Good Manufacturing Practices (cGMP) compliance and efficiency. </li><li> Define requirements and specifications for equipment. </li><li> Ability to work independently, set priorities, and drive results at the same time able to work on a production team driving team goals. </li><li> Work hands on to troubleshoot and understand Sustainability impact to the site & utilities systems and equipment issues around the site. </li></ul> BUSINESS EXPERTISE: <ul><li> Applies skills to align work activities with department objectives </li><li> Project management (manages project priorities - schedule & cost, installation). </li><li> Extensive industrial experience involving utility system generation, distribution and controls are needed. Engineer must be have in depth experience (without further skills training) working with industrial utility generation equipment - Boilers, Chillers, Compressors, Pumping distribution systems, etc </li><li> Must be fully aware of requirement specifications from a qualification perspective (IC/OC, IQ/OQ, CRs, etc.) </li><li> Actively search for ideas and ways to reduce expenses and improve quality without compromising superior customer service. </li></ul> FUNCTIONAL EXPERTISE: <ul><li> Lead in the identification and implementation of process improvement projects, productivity initiatives and corrective actions while focusing on equipment up-time, minimizing cost and maintaining process consistency </li><li> Perform a thorough review of design & engineering records and related Good Manufacturing Practices documentation, identifying and resolving discrepancies in a timely manner, and implementing corrective actions to improve the execution/review process for equipment. </li><li> Develop training material. Working as a subject matter expert (SME), provide necessary training for system maintenance. </li><li> Work alongside operations and lean six sigma team members to develop reliable, consistent manufacturing processes that meet current Good Manufacturing Practices requirements. </li><li> Knowledgeable of all utility systems regarding functionally of equipment and relied on as SME during regulatory discussions for Utilities and the commissioning of that equipment. </li></ul> PROBLEM SOLVING: <ul><li> Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units </li><li> The successful candidate must have strong problem-solving skills and a hands-on approach to problem solving. The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and identify root cause and then fix then fix implement corrective and preventative actions to prevent repeat failures. </li><li> Responsible for the identification, development, and implementation of new systems which enhances the operation of Plant Engineering processes. </li><li> Assist with trouble shooting Plant Engineering equipment on an as needed basis which includes but limited to chillers, boiler, AHUs, PLCs, humidifiers/dehumidifies, water systems, Square D controllers/monitors, clean steam generators, refrigeration systems, and cryogenic storage. </li><li> Perform engineering task as needed to maintain plant utilities equipment. </li></ul> IMPACT : <ul><li> Explains difficult concepts and persuades others to adopt point of view. </li><li> Communicates information, asks questions and checks for understanding. Provide clarification in person and in writing for streamlined communication. </li></ul> ACCOUNTABILITY <ul><li> Accountable for the their own performance and performance of sustainability program & support of plant engineering systems and maintenance. </li></ul> DECISION MAKING <ul><li> Makes decisions - guided by policies, guidelines, design practices, and procedures - that impact the department's ability to meet performance objectives </li><li> Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes </li></ul> STRATEGIC PLANNING: <ul><li> Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges </li><li> Consults on an as-needed basis with next-level manager for newly identified priorities. </li><li> Lead initiatives and see through to completion. </li><li> Responsible for the identification and implementation of preventative and predictive maintenance programs to assure compliance with quality, regulatory, and reliability requirements and goals. </li><li> Utilize maintenance and reliability metrics and key performance indicators. Benchmark performance indicators against industry data. Look for continuous improvements opportunities </li></ul> RESOURCE MANAGEMENT: <ul><li> Forecasts resource needs; manages allocated expense budgets for tasks </li><li> Forecasts resource needs; manages allocated resources to implement projects </li><li> Working Relationships </li><li> Reports to Plant Engineering Manager </li><li> Frequent interaction with employees from other departments </li><li> Interacts with representatives from regulatory agencies </li><li> Collaborates with the production area maintenance technicians and engineers to maintain utility up-time for all production equipment. </li><li> Identifies revisions, deletions, or additions to the calibration and maintenance programs to ensure that calibration and maintenance activities are completed in accordance with established safety, Good Manufacturing Practices (GMP), and calibration/maintenance procedures. </li><li> Establish processes that ensure required Safety guidelines are followed and participates in divisional Safety Audit activities </li><li> Assists in deviation investigations for maintenance instruments, equipment, and systems. </li></ul> Position Qualifications: Education Minimum Requirement: <ul><li> Bachelor's Degree in Engineering, Science or related field </li></ul>Required Experience and Skills:<ul><li> Five years of experience in a production and/or calibration and/or maintenance background </li><li> Strong planning, scheduling, and time management skills </li><li> Good oral and written communication skills </li><li> SAP experience related to plant maintenance and spare parts procurement systems </li><li> Experience with formal problem solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA, and/or Lean Six Sigma tools. </li><li> Familiarity of World Class" maintenance practices is paramount (e.g. PMs, RCM, PdM, etc.) </li><li> Fully proficient in understanding the functionality of all utility generation equipment (e.g. electrical distribution, clean utilities - Boilers, Chillers, wfi/clean steam, HVAC/R, and utility generation equipment. </li><li> Utility and HVAC system process improvement and optimization experience </li><li> Technical writing and deviation investigation experience </li><li> Experience in managing a project portfolio and/or a program with strategic initiatives. </li><li> Experience in problem solving and troubleshooting </li><li> Familiarity with cGMPs and vaccine regulatory requirements. </li></ul> Preferred Experience and Skills: <ul><li> Sustainability SME and related certifications </li><li> CMMS experience related to plant maintenance and spare parts procurement systems </li><li> Project management, including change control and equipment qualification </li><li> SAP experience related to plant maintenance and spare parts procurement systems </li><li> Familiarity with current Good Manufacturing Practices experience in a sterile, bulk or finished pharmaceutical environment </li><li> Experience in automation and manufacturing execution systems (MES), process modeling and process improvement. </li><li> Mechanical functionality and reliability knowledge (asset management) </li><li> Green Belt/Black Belt Certification </li><li> Professional Engineer VetJobs #EBRG's </li></ul>Required Skills: Accountability, Accountability, Adaptability, Capital Project Management, cGMP Regulations, Change Management, Communication, Curriculum Development, Data Analysis, Engineering Processes, Equipment Qualification, Facility Management, Good Manufacturing Practices (GMP), Leadership, Maintenance Supervision, Occupational Safety and Health, Process Improvement Projects, Productivity Improvements, Project Management, Regulatory Audits, Regulatory Compliance, Sterile Manufacturing, System Maintenance, Team Leadership, Third Party Vendors {+ 1 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $114,700.00 - $180,500.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 01/9/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R378154

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Senior Specialist Sustainability & Utility Engineer

Job Description We are seeking a motivated and experienced Translational PET Imaging Scientist to lead the transition of novel PET radiotracers from late preclinical development into first-in-human studies. This role will primarily focus on clinical implementation of novel PET tracers in oncology studies, guide regulatory submissions, and act as the PET imaging expert within multidisciplinary project teams to ensure efficient clinical translation. Key Responsibilities:<ul><li> Strategy & leadership : Develop and lead the clinical imaging strategy for application of novel PET tracers in early clinical oncology trials, guiding projects from late-stage preclinical work through clinical proof-of-concept studies.</li><li> Translational study design : Design, oversee, and interpret PET imaging studies in animal models and early-phase clinical trials (Phase I), ensuring robust study design and high-quality PET data collection.</li><li> Regulatory support : Familiarity with regulatory and quality frameworks applicable to radiopharmaceuticals (GMP for radiopharmaceuticals, IND/CTA requirements, radiation safety/compliance). Prepare and contribute PET-specific scientific content for regulatory filings, including IND submissions.</li><li> Partner and site management : Coordinate with CROs, CDMOs, and clinical sites to support cGMP manufacturing logistics and clinical supply/distribution for radiopharmaceuticals. Manage relationships and deliverables with external academic collaborators and CROs/CDMOs</li><li> Cross-functional collaboration : Serve as the PET imaging subject-matter expert on project teams, working closely with biomarker scientists, clinical and medical leads, regulatory affairs, clinical operations, and CMC teams.</li><li> Reporting & dissemination : Interpret imaging data, author study reports, present findings internally and externally, and contribute to manuscripts and conference presentations.</li></ul>NOTE: This role is available in South San Francisco, CA; Boston, MA; West Point, PA or Rahway, NJ based on candidate preference. Qualifications: Education:<ul><li>Ph.D. or equivalent doctorate degree in Biomedical/Imaging Science, Radiochemistry, Physics, Pharmacology or a related field and seven (7) years of relevant experience.</li></ul>Required Experience and Skills:<ul><li>Demonstrated experience advancing novel PET tracers into clinical studies, including collaboration with academic sites and contract partners for cGMP manufacturing.</li><li>Experience as imaging lead on Phase I oncology trials and direct involvement in first-in-human novel PET tracer studies, including lead contributor to protocol design.</li><li>Strong understanding of radiopharmaceutical development, radiochemistry, and quality control; proven ability designing quantitative PET studies across species.</li><li>First-hand experience with regulatory pathways and requirements for novel PET tracers in early-phase clinical trials.</li><li>Track record of interacting with regulatory agencies or primary contributor to successful agency submissions for novel PET imaging agents.</li><li>Excellent written and verbal communication skills, with a track record of effective collaboration across multidisciplinary teams.</li></ul>#EligibleforERP Required Skills: Cancer Research, Clinical Trials, Oncology, Oncology Trials, Positron Emission Tomography (PET), Project Leadership, Radiation Safety, Radiopharmaceuticals, Radiopharmacy, Regulatory Compliance, Regulatory Work, Technical Leadership, Translational Research Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $169,700.00 - $267,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic/International VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 01/31/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R378617

Principal Scientist, Translational PET Imaging

Job Description Our engineers and scientists support internal and external manufacturing operations to remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our technical personnel have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. Summary, Focus and Purpose The Vaccines Technology Specialist position is responsible for providing technical support to primary filling, inspection, and/or packaging operations within the vaccine manufacturing facility at the Wilson, NC Site. This position will be an individual contributor and member of the Technical Operations Team within the Rota-POD Integrated Process Team. This is an engineering role focused on the technical & commercial readiness of the vaccine manufacturing facility as well as providing future routine operational support. For their area of assignment, the selected candidate will be the technical subject matter expert for all aspects of tech transfer, validation, licensure, start up, and ongoing technical support. Key Functions Delivery <ul><li>Utilize technical expertise, experience, independent judgment, and decision-making to build robust processes that support consistent and reliable supply</li><li>Resolve and escalate technical issues impacting supply within the daily, weekly, and monthly IPT management processes</li><li>Lead or support equipment process development, troubleshooting and validation activities</li></ul> Compliance <ul><li>Ensure that assigned processes are developed in a robust manner and defined such that vaccines filled at the Wilson site consistently meet critical quality attributes</li><li>Act as or support technical subject matter expert(s) during regulatory inspections for area of assignment</li><li>Ensure that process development and validation data is generated, documented and presented in a manner that supports successful licensure and positive interactions with regulatory agencies</li><li>Lead or support change management for the Rota-POD IPT and provide scientific/technical justification for proposed changes to support business needs</li><li>Investigate, determine root cause, and implement robust Corrective Action and Preventive Actions and author quality investigations for any applicable process related compliance discrepancies noted during day-to-day activities and/or audits, and escalate these issues per IPT management processes</li></ul> Cost <ul><li>Ensure that Technical related activities for area of assignment are managed such that process deliverables and timelines are well defined in advance and met</li><li>Recommend continuous improvement, productivity, and capital projects for the IPT</li></ul> Continuous Improvement <ul><li>Execute projects that support the strategic goals of the Rota-POD IPT</li><li>Maintain a culture of continuous improvement focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving</li></ul>Education<ul><li>Bachelor's degree or higher in Science or Engineering field (Engineering preferred)</li></ul>Required Experience | Knowledge | Skills<ul><li>Two years of relevant industry work experience, with one year experience providing technical/development support to pharmaceutical unit operations</li><li>Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry</li><li>Technical writing experience with investigations, change requests, standard operating procedures, batch records, protocols, etc.</li><li>Demonstrated ability to work independently as team member</li><li>Demonstrated strong interpersonal skills with ability to influence and support others through a culture of inclusion, feedback, and empowerment</li><li>Willing to work irregular hours to support multi-shift operation on an extended or as needed basis</li></ul>Preferred Experience | Knowledge | Skill<ul><li>Experience with aseptic filling, qualified inspection processes, pharmaceutical packaging and/or serialization/aggregation</li><li>Experience in production ramp up of capital projects</li><li>Experience in authoring quality deviations</li><li>Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies</li><li>Familiarity with Change Execution Management tools</li><li>Working knowledge with Systems Applications and Products (SAP) / Manufacturing Execution System (MES)</li><li>Experience working in a Center for Biologics Evaluation and Research (CBER) regulated environment</li><li>Demonstrated data analysis skills and experience setting up process control limits using advanced Excel and/or statistical software packages (Minitab or JMP)</li><li>Experience supporting regulatory inspections including FDA</li></ul>Required Skills: Adaptability, Adaptability, Analytical Instrumentation, Automation Systems, Bioprocessing, Capital Projects, cGMP Compliance, Change Control Processes, Change Request Management, Computerized Maintenance Management Systems (CMMS), Continuous Process Improvement, Data Analysis, Detail-Oriented, Electrical Systems, Global Manufacturing, Lean Manufacturing, Lean Product Development, Maintenance Supervision, Mechanical Systems, Organizational Change Management, Pharmaceutical Packaging, Process Control, Regulatory Compliance, Regulatory Inspections, SAP Manufacturing Execution (SAP ME) {+ 2 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $85,600.00 - $134,800.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 01/5/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R377250

Specialist, Engineering

Job Description Applications are being sought for an associate director position in our Research and Development Division Biologics Pilot Plant (BPP) automation engineering group. Individual will utilize technical expertise to lead and perform various automation activities supporting pilot-scale campaigns for the GMP manufacture of bulk biologic (vaccines and therapeutic proteins) clinical supplies. Candidate will participate in a range of activities including, but are not limited to: Primary Responsibilities: <ul><li> Provide expertise in multiple automation platforms utilized in the BPP </li></ul><ul><li> Provide technical training and mentoring within the automation group and cross-functional. </li></ul><ul><li> Work with the team to innovate and evaluate new technologies and automation systems to improve the pilot plant's reliability and increase efficiencies </li></ul><ul><li> Author and review GMP change controls, test protocols, SDLC documentation, SOP's, safety reviews, deviation investigations and actions. </li></ul><ul><li> Lead ongoing automation system support and troubleshooting in the facility </li></ul><ul><li> Lead the design, scope, implementation, and GMP close out of pilot plant projects including the specification and automation integration of new equipment, upgrades and improvements. </li></ul><ul><li> Provide automation leadership for GMP clinical manufacturing campaigns in the facility </li></ul><ul><li> Cross-train in many areas and technologies. </li></ul><ul><li> Actively work in a multi-discipline cross-functional project team environment </li></ul> In addition to the core responsibilities outlined above, an opportunity exists to collaborate across our Research and Development Division and our Manufacturing Division with automation and data initiatives. Some off shift (second shift and weekends) will be required to support campaigns. Education Minimum Requirement: <ul><li> Bachelor's degree in engineering with a minimum of 7 years of relevant manufacturing automation experience. </li></ul> Required Experience and Skills: <ul><li> Highly motivated with the ability to work in a fast-paced and dynamic setting. </li></ul><ul><li> Significant experience in multiple BPP automation technologies: Ignition, DeltaV, Rockwell PLC, PI, PI Asset Framework, OPC interfaces, Unicorn, Firewall Rulls, IT/OT technologies and software. </li></ul><ul><li> Demonstrated ability to train individuals and influence functional groups. </li></ul><ul><li> Previous automation experience supporting GMP production of pharmaceuticals, biopharmaceuticals, or vaccines. This includes executing GMP change controls, System Development Life Cycle (SDLC) documentation, and data integrity principles. </li></ul><ul><li> Strong project management, organizational, communication and leadership skills </li></ul><ul><li> Ability to work independently and in a team environment </li></ul> Desired Experience and Skills: Experience with manufacturing equipment, process control, automation infrastructure design, and/or cybersecurity. Experience with integrating equipment automation systems with Enterprise IT managed systems, e.g. MES, virtualization, networking, windows and antivirus patching/updates. Experience with Project Management Methodologies (Agile, Waterfall, etc.) and Tools (MS Project, RACI, GANTT). Experience with building and planning technology road maps. Experience with biologics manufacturing equipment (bioreactors, filtration skids, chromatography skids). Experience supporting GMP audits. PRD Required Skills: Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $139,600.00 - $219,700.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 01/9/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R377259

Associate Director, Biologics Pilot Plant Automation

Job Description Discovery Biologics is seeking an Associate Director with experience in biologics and data science to expand our abilities to design and engineer biotherapeutics. We are building a department that directly integrates computational and wet-lab researchers with state-of-the-art automation to accelerate the discovery of novel biologics. We are a highly diverse and collaborative group of biologists, engineers, and computer scientists working at the edge of computation, disease biology, and biotherapeutics. We collaborate broadly within our Company and with academic and industry partners to accelerate the pace of biologics discovery and engineering. We recognize that the diversity in our team is our strength and we are committed to creating an inclusive environment for all employees. Successful candidates must demonstrate inclusive behaviors in working with a diverse group of researchers to drive our core mission. Position Description: This is an individual contributor role with project leadership responsibilities. The successful candidate will work side-by-side with wet-lab researchers to design experiments and build datasets that enable machine learning to predict improved biologics. They will contribute to the identification and application of computational tools that enable the discovery and engineering of biologics. They will partner broadly across Discovery Biologics, Data Science, and IT to implement systems and practices that support high throughput data capture, integration, and the generation of predictive models. As part of project teams, they will analyze diverse multidimensional data to enable teams to drive programs forward. As part of technology development teams, they will pursue novel research that enhances our ability to collect and learn from large datasets. They will mentor, coach, and train fellow researchers. The successful candidate will join a diverse group of innovative researchers who are driving the next revolution in biologics discovery and engineering. Key Responsibilities <ul><li> Develop data science based predictive models for biologics to advance early phase drug discovery programs </li><li> Develop computational routines and custom visualizations that enable project teams to impact protein engineering designs and allow teams to rapidly make program decisions from real-time data </li><li> Collaborate across groups to systematize and automate the process of capturing raw instrument data and preparing it for storage and analysis </li><li> Provide technical expertise and leadership for data science working groups and teams </li><li> Author and contribute to presentations, publications, and patents </li><li> Foster a high-performance culture of collaboration, engagement, self-accountability and inclusion </li></ul> Position Qualifications: Minimum Education Requirement: <ul><li> PhD in Computational Biology, Biostatistics, Biochemistry, Computer Science, Biology, Engineering/Bioengineering, Structural Biology, Biophysics, Chemistry or related STEM discipline with demonstrated expertise in biologics and data science and 4+ years of industry experience </li><li> MS and 8+ years or </li><li> BS +12 years of experience </li></ul> Required Experience: <ul><li> Fluency in at least one modern programming language such as Python, Java or similar; fluency in using version control systems (Git) and branching strategies. </li><li> Strong expertise in data science and data engineering workflow and best practices for life science applications </li><li> Experience working with relational database (SQL) and non-relational database, and designing data models </li><li> Experience in designing, implementing, and maintaining modern data architecture, using the state-of-the-art tools for large scale data applications, such as Airflow, DBT, Kafka, Debezium, Docker, Kubernetes, Datadog </li><li> Extensive experience as a developer using any major cloud platforms (AWS, GCP, Azure) </li><li> Experience in working with microservices and API development </li><li> Ability to teach biologists and biochemists the fundamentals of data science </li><li> Demonstrated ability to succeed in a collaborative, multidisciplinary team environment </li><li> Excellent written and oral communication skills </li><li> Champion for diverse and inclusive culture </li><li> Mentor and coach group members to complement and strengthen their team </li></ul> Preferred Experience and Skills: <ul><li> Experience with NGS data processing and analysis applied to biologics discovery highly preferred </li><li> Full stack developer experience highly preferred </li><li> Experience with Scientific Data Life Cycle (SDLC) documentation highly preferred </li><li> Experience with protein engineering or the discovery and development of biologics </li><li> Experience with multiple types of protein structure and sequence representations, featurization, and embeddings </li><li> Experience with protein modeling software (e.g. AlphaFold, Rosetta, TrRosetta, MOE, GROMACs, or similar) </li><li> Familiarity with data visualization tools and libraries </li><li> Experience in DevOps, DataOps, and ML Engineering </li></ul>#EligibleforERP Required Skills: API Development, Biopharmaceuticals, Computer Science, Data Analysis, Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Programming Languages, Python (Programming Language), Relational Database, Scientific Data Management, Software Development, Stakeholder Relationship Management, Statistics, Structured Query Language (SQL) Preferred Skills: Computational Biology, Full Stack Development, Machine Learning (ML), Next Generation Sequencing (NGS), NGS Data Analysis, Protein Engineering, Protein Modeling, Software Development Life Cycle (SDLC) Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $156,500.00 - $246,300.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/6/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R378169

Associate Director , Data Science, Discovery Biologics

Job Description GENERAL SUMMARY : The Utility Engineer is a member of the Plant Engineering team providing direct hands-on technical support to the Durham Site. The site includes an Energy Center, Vaccines DP and DS Manufacturing Facilities, Quality Labs, various other manufacturing buildings and Maintenance and Material Storage Facility (MMSF). This support position will focus on leading investigation of Electrical system excursions, engineering maintenance, design system improvements and optimizations and hands on troubleshooting. This individual will provide input to the deviation investigation process for determination of root cause, recommend corrective actions to prevent re-occurrence and help assess the impact on operations. The incumbent will also be responsible for leading plant engineering's improvement projects and implementation of productivity enhancement initiatives. GENERAL PROFILE: <ul><li>Individual contributor role working with professional employees and/or contractors.</li><li>Contributes to the performance and results of the department.</li><li>Adapts departmental plans and priorities to address resource and operational challenges.</li><li>Decisions are guided by policies, procedures and business plan; receives guidance from manager.</li><li>Provides technical guidance to employees, colleagues or contractors</li><li>Anticipates and interprets client and/or customer needs to identify solutions</li><li>Works as a liaison between Plant Engineering and other Site Business Partner's</li><li>Team member for small capital projects for plant engineering</li><li>Ensures utility operations daily priorities and schedules project/work meeting the criteria established by site objectives.</li><li>Support / lead major utility equipment related projects, scope including funding, change control, integration, commissioning, and equipment qualification</li><li>Obtains bids, reviews contracts, supervises, and follows-up on contract work including.</li><li>Actively Participates in and contributes to shutdown schedule including all maintenance, calibration, capital project work, and GMP Cleaning for all facility shutdowns</li><li>Coordinates with Site Engineering and IPT production planners</li><li>Attends daily shutdown meetings ensuring owned activities are tracked and completed</li><li>systems and process equipment. Provides technical support and training to mechanics and other maintenance personnel.</li><li>Interface with safety, production, and quality groups to ensure facility operations and systems comply with required standards.</li><li>Lead/ participate in discussions with contractors, vendors, or other third-party organizations as necessary to ensure consistency with overall maintenance and reliability objectives.</li><li>Participate in cross-functional teams for engineering Operations projects, or other plant activities as needed.</li><li>Works to streamline and improve Maintenance department systems, procedures and ways of working with a focus on safety, current Good Manufacturing Practices (cGMP) compliance and efficiency.</li><li>Define requirements and specifications for equipment.</li><li>Manage the implementation of new equipment and/or the modifications to existing equipment</li><li>Be the lead with regards to installation, upgrades, and dependability issues, and lead or assist in trouble shooting processes or equipment issues.</li><li>Ability to work independently, set priorities, and drive results at the same time able to work on a production team driving team goals.</li><li>Work hands on to troubleshoot and understand electrical system and equipment issues around the site.</li><li>Assists in deviation investigations for maintenance instruments, equipment, and systems</li></ul> BUSINESS EXPERTISE: <ul><li>Applies skills to align work activities with department objectives</li><li>Project management (manages project priorities - schedule & cost, installation).</li><li>Extensive industrial experience involving utility system generation, distribution and controls are needed. Engineer must be have in depth experience (without further skills training) working with industrial utility generation equipment - Boilers, Chillers, Compressors, Pumping distribution systems, etc</li><li>Must be fully aware of requirement specifications from a qualification perspective (IC/OC, IQ/OQ, CRs, etc.)</li><li>Actively search for ideas and ways to reduce expenses and improve quality without compromising superior customer service.</li></ul> FUNCTIONAL EXPERTISE: <ul><li>Lead in the identification and implementation of process improvement projects, productivity initiatives and corrective actions while focusing on equipment up-time, minimizing cost and maintaining process consistency</li><li>Provide input to investigate deviations (both minor and major), with responsibility to interface with Operations, Global Vaccine Technology (GVTE), Automation, and Quality approvers. </li><li>Perform a thorough review of design & engineering records and related Good Manufacturing Practices documentation, identifying and resolving discrepancies in a timely manner, and implementing corrective actions to improve the execution/review process for equipment.</li><li>Develop training material. Working as a subject matter expert (SME), provide necessary training for system maintenance.</li><li>Work alongside operations and lean six sigma team members to develop reliable, consistent manufacturing processes that meet current Good Manufacturing Practices requirements.</li><li>Knowledgeable of all utility systems regarding functionally of equipment and relied on as SME during regulatory discussions for Utilities and the commissioning of that equipment.</li></ul> PROBLEM SOLVING: <ul><li>Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units</li><li>The successful candidate must have strong problem-solving skills and a hands-on approach to problem solving. The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and identify root cause and then fix then fix implement corrective and preventative actions to prevent repeat failures.</li><li>Responsible for the identification, development, and implementation of new systems which enhances the operation of Plant Engineering processes.</li><li>Assist with trouble shooting Plant Engineering equipment on an as needed basis which includes but limited to chillers, boiler, AHUs, PLCs, humidifiers/dehumidifies, water systems, Square D controllers/monitors, clean steam generators, refrigeration systems, and cryogenic storage.</li><li>Perform engineering task as needed to maintain plant utilities equipment.</li></ul> IMPACT :<ul><li>Influence</li><li>Explains difficult concepts and persuades others to adopt point of view.</li><li>Communicates information, asks questions and checks for understanding. Provide clarification in person and in writing for streamlined communication.</li></ul> ACCOUNTABILITY <ul><li>Accountable for their own performance and performance of plant engineering systems and maintenance.</li></ul> DECISION MAKING <ul><li>Makes decisions - guided by policies, guidelines, design practices, and procedures - that impact the department's ability to meet performance objectives</li><li>Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes</li></ul> STRATEGIC PLANNING: <ul><li>Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges</li><li>Consults on an as-needed basis with next-level manager for newly identified priorities.</li><li>Lead initiatives and see through to completion.</li><li>Responsible for the identification and implementation of preventative and predictive maintenance programs to assure compliance with quality, regulatory, and reliability requirements and goals.</li><li>Track maintenance and reliability metrics and key performance indicators. Benchmark performance indicators against industry data. Look for continuous improvements opportunities</li></ul> RESOURCE MANAGEMENT: <ul><li>Forecasts resource needs; manages allocated expense budgets for tasks</li><li>Forecasts resource needs; manages allocated resources to implement projects</li><li>Working Relationships</li><li>Reports to Plant Engineering Manager</li><li>Frequent interaction with employees from other departments</li><li>Interacts with representatives from regulatory agencies</li><li>Collaborates with the production area maintenance technicians and engineers to maintain utility up-time for all production equipment.</li><li>Identifies revisions, deletions, or additions to the calibration and maintenance programs to ensure that calibration and maintenance activities are completed in accordance with established safety, Good Manufacturing Practices (GMP), and calibration/maintenance procedures.</li><li>Establish processes that ensure required Safety guidelines are followed and participates in divisional Safety Audit activities</li><li>Assists in deviation investigations for maintenance instruments, equipment, and systems.</li></ul> Position Qualifications: Education Minimum Requirement:<ul><li>Bachelor's degree in engineering, Science or related field</li></ul>Required Experience and Skills:<ul><li>Five years of experience in a production and/or calibration and/or maintenance background</li><li>Strong planning, scheduling, and time management skills</li><li>Working knowledge regulatory requirements in accordance with GMP manufacturing operations</li><li>Good oral and written communication skills</li><li>Experience with GMP compliant calibration and maintenance databases</li><li>SAP experience related to plant maintenance and spare parts procurement systems</li><li>Experience with formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA, and/or Lean Six Sigma tools.</li><li>Familiarity of World Class" maintenance practices is paramount (e.g. PMs, RCM, PdM, etc.)</li><li>Fully proficient in understanding the functionality of all utility generation equipment (e.g. electrical distribution, clean utilities, Boilers, Chillers, wfi/clean steam, HVAC/R, and utility generation equipment.</li><li>Utility and HVAC system process improvement and optimization experience</li><li>Technical writing and deviation investigation experience</li><li>Experience in problem solving and troubleshooting</li><li>Familiarity with cGMPs and vaccine regulatory requirements.</li></ul>Preferred Experience and Skills:<ul><li>CMMS experience related to plant maintenance and spare parts procurement systems</li><li>Project management, including change control and equipment qualification</li><li>SAP experience related to plant maintenance and spare parts procurement systems</li><li>Familiarity with current Good Manufacturing Practices experience in a sterile, bulk or finished pharmaceutical environment</li><li>Experience in automation and manufacturing execution systems (MES), process modeling and process improvement.</li><li>Mechanical functionality and reliability knowledge (asset management)</li><li>Green Belt/Black Belt Certification</li><li>Professional Engineer VetJobs #EBRG's</li></ul>Required Skills: Adaptability, Business Planning, Capital Project Management, cGMP Regulations, Change Management, Curriculum Development, Data Analysis, Deviation Investigations, Equipment Qualification, Facility Management, Good Manufacturing Practices (GMP), Implementation Management, Maintenance Supervision, Occupational Safety and Health, Process Improvement Projects, Productivity Improvements, Project Management, Regulatory Audits, Sterile Manufacturing, System Maintenance, Team Leadership, Troubleshooting, Utility Plant Operations Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $114,700.00 - $180,500.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 01/9/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R378155

Senior Specialist, Engineering

Job Description Associate Specialist - MACS Operations Specialist (P1) Description The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides operations experience and a strong understanding of engineering fundamentals. The MACS Operations Specialist position will report to the Associate Director, Engineering and will be a member of the EF Team at the Rahway NJ facility. EF is responsible for development of new technologies/capabilities, execution of capital and non-capital improvement projects, and interfacing with the automation system assets spanning production, utility systems and associated infrastructure. Responsibilities of the Operations Specialist include the following: The Operations Specialist role at the Associate Specialist level will serve as an operations team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center. This is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant under construction in Rahway, New Jersey. They will serve as a team member for the MACS Center construction and startup phase and will go on to support new and/or existing facilities across the Small Molecule Process Research & Development (SM PR&D) network. As the facility is currently under construction, the selected candidate will contribute to equipment and facility design, equipment or material testing, system commissioning/qualification, as well as other critical activity workstreams to enable facility startup. Additionally, the selected candidate will be a key contributor to the Operational Readiness program with the purpose of establishing the procedures, documentation, and training necessary to operate and maintain a new business area after completion of the facility startup. The selected candidate is expected to be a key part of the operations team and foster a culture of collaboration, learning and innovation. They will collaborate closely with the development engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies. Once the MACS Center is operational, additional tasks could include equipment setups, raw material sampling and subdivisions, solution preparations, batch processing planning and execution at a pilot scale, process knowledge capture, and troubleshooting equipment with the aim of advancing process development, aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve handling of a variety of reagents, solvents, and active pharmaceutical ingredients during wet chemistry" operations (performing chemical reactions, extractions, distillations, crystallizations, filtration, drying, etc.) as well as dry powder processing (e.g., dry milling). Additional Supported Areas As required and in addition to support of current capital projects the Associate Specialist may provide direct support to other areas such as: Small Scale Organics Pilot Plant (SSO): The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in the Process Research and Development (PR&D) organization. The pilot plant's mission is to serve as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites. Prep Lab Area : The Prep Lab is used to generate data which contributes to process definition and provides Phase I/IIa clinical material when needed. This kilo scale capability establishes reaction parameters and ensures successful batches when transferring to pilot scale. The Prep Lab includes a cleanroom suite for GMP small-scale manufacturing of potent and multi-modality clinical materials. Areas of the Prep Lab have been and are continuing to be upgraded to support pipeline programs such as ADCs, PDCs, and other cross modality compounds that require a more flexible potent compound processing space. Education Minimum Requirement: Bachelor's degree in Chemical Engineering, Chemistry, Biology, Pharmaceutical Sciences or related scientific field plus one (1) year relevant work experience - OR - Associate in Science, Associate in Applied Science (ideally in Process Technology), or Associate degree in a relevant technical field of study plus at least six (6) years experience - OR - High School Diploma/GED plus at least eight (8) years of relevant experience in Pharmaceutical, Chemical, Petrochemical or Food Processing/Manufacturing. Required Experience and Skills: <ul><li> Effective interpersonal and communication skills, both verbal and written. </li></ul><ul><li> Excellent organizational skills to multi-task. </li></ul><ul><li> Desire and willingness to learn, contribute and lead. </li></ul><ul><li> Track-record of independent problem-solving. </li></ul><ul><li> Strong communication skills to discuss technical problems and a collaborative mindset to interface with cross-functional teams. </li></ul><ul><li> A strong mechanical aptitude. </li></ul><ul><li> Proficiency in technical writing and the use of word processing, spreadsheet, graphing, and presentation software. </li></ul><ul><li> This role will require working on 8-hour shifts that are currently one common shift across the Operations team but will later rotate between 1st and 2nd shift on alternating weeks as the MACS Center is coming online and in full operations. Onsite presence is required five days a week. Occasional overtime work may be required based on business needs. </li></ul> Desired Experience and Skills: <ul><li> Experience working in a GMP clinical or manufacturing supply facility. </li></ul><ul><li> Experience with GMP facility design, equipment start-up and/or qualification. </li></ul><ul><li> Experience with small molecule drug substance and/or biologics process development. </li></ul><ul><li> Experience in supporting compliance investigations and change management. </li></ul><ul><li> Ability to prepare or leverage Standard Operating Procedures (SOP) and cGMP documents. </li></ul><ul><li> Experience operating/maintaining pilot scale or prep lab scale equipment. </li></ul><ul><li> Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA) </li></ul><ul><li> Experience with Potent Compound processing and containment systems (e.g., isolators), or clean room facilities. </li></ul><ul><li> Experience interacting with or overseeing the management of process utility system associated with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems, etc. </li></ul><ul><li> Experience working in an environment with an Automation System (DeltaV, PLC, etc.). </li></ul><ul><li> Operations experience in pilot plant or manufacturing environment. </li></ul><ul><li> Familiarity with the administration of cGMPs , Good Documentation Practices (GDPs), and S&E regulations as it pertains to pharmaceutical development. </li></ul><ul><li> Lean Six Sigma Training / Certification. </li></ul>#eligibleforERP #PRD PRD MSJR Required Skills: Accountability, Accountability, Applied Engineering, Assembly Operations, Biochemistry, Chemical Engineering, Communication, GMP Compliance, Good Manufacturing Practices (GMP), Hazard Analysis, HR Programs, Machinery Operation, Mechanical Apptitude, Operations Management, Operations Support, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance, Process Technologies, Production Efficiencies, Production Process Development, Production Scheduling, Raw Material Sampling, Risk Control Assessment, Safety Protocols {+ 5 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $70,500.00 - $110,900.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 12/21/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R378461

Associate Specialist, Operations (Onsite)

Job Description Field Access Manager The Field Access Manager (FAM) serves as the subject-matter expert on access related issues for healthcare professionals (HCPs) and healthcare organizations (HCOs), and will work cross-functionally with patient support, market access, and field sales to support timely patient access to therapy. The FAM will provide information to providers on access processes, reimbursement issues, and support patient assistance programs, all while ensuring compliance with healthcare regulations. The FAM role is a remote/field-based role that proactively provides approved education to defined accounts within an assigned geography on matters related to access and coverage to facilitate appropriate patient access. The FAM will analyze access issues and act as the local access resource for HCPs and other field force personnel and region management, as permitted by policy. Where appropriate, the FAM will coordinate with the access hub concerning individual patient cases including patient access and coverage assistance, hub enrollment and overall coordination. The FAM will need to collaborate cross functionally with Field Sales, Marketing, Market Access, Public Affairs, State and Government Affairs, Trade and Specialty Pharmacy Accounts while abiding by all corporate and industry policy and procedures. Joining this team means being a part of driving meaningful patient impact by utilizing our scientific expertise and serving as the primary contact for customers within your assigned territory: Indianapolis IN, South Bend IN, Lafayette IN The FAMs will manage daily activities that support appropriate patient access. Activities include, but are not limited to: &bull; Provide information and/or education to HCP accounts on patient access, including benefit verification, prior authorization process, appeals process, and patient support programs in both live and virtual formats &bull; Analyze access trends &bull; Partner cross-functionally to identify and address barriers to patient access and supporting patient satisfaction &bull; Build collaborative, trusted relationships with internal stakeholders to support seamless patient access to therapy &bull; Monitor payer trends to address access barriers &bull; Provide access information to HCP offices &bull; Provide access education to field teams upon approved direction. &bull; Escalate and coordinate on access issues with third parties including hub vendor &bull; Provide education and support on Specialty Pharmacy issues &bull; Provide information to HCP offices on how the products are covered under the benefit design (Commercial, Medicare, Medicaid) &bull; Answer questions about coverage, including payer-specific access questions &bull; Maintain deep knowledge of regional and national market dynamics, and payer coverage policies. &bull; Act as a subject matter expert on access and affordability challenges across various payer types, including Medicare, Medicaid, and commercial plans &bull; Educate and update HCPs on key private and public payer coverage and changes that impact access for patients &bull; Support patient access to the product by providing subject matter expertise on payer coverage issues impacting product access in a manner that complies with policies, processes and standard operating procedures &bull; Educate HCP offices on the product hub program including, e.g., patient support offerings, financial assistance and hub educational resources &bull; Demonstrate knowledge of and communicate information about access resources and payer processes/policies &bull; Attend National and Regional Meetings Minimum Requirements: &bull; Bachelor's Degree; 7+ years' experience in patient support, healthcare sales or operations, project management, or reimbursement support &bull; Strong knowledge of health insurance structures (Medicare Part B, Medicaid, commercial) and related access processes, including benefit verification, prior authorization, and appeal processes &bull; Expertise in pharmaceutical compliance and HIPAA regulations regarding patient confidentiality &bull; Excellent interpersonal and communication skills; demonstrated ability to engage and influence diverse stakeholders across teams and disciplines &bull; Exhibit competent understanding of hub and patient support activities &bull; Proven ability to manage multiple priorities in a hybrid environment with 20-25% travel; Must reside in the assigned territory/metro area &bull; Ability to operate as a team player" in collaborating with multiple sales representatives, sales leadership, and internal colleagues appropriately to reach common goals &bull; Must be at least 21 years old with a valid driver's license and a clean driving record Preferred Requirements: &bull; Pharmaceutical industry experience highly preferred &bull; Deep understanding of HCP office workflows, prescription flow, and clinic operations; pulmonology experience preferred respsales Required Skills: Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $114,700.00 - $180,500.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 75% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): n/a Job Posting End Date: 01/1/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R375943

Field Access Manager - Central Indiana - Indianapolis IN, South Bend IN, Lafayette IN

Job Description This role is responsible for regional category management and sourcing leadership of Creative, Digital Production & Publishing, and Medical Education within Marketing Procurement, focused on a global mindset through collaboration with Human Health business partners as well as regional and/or local sourcing professionals in a matrix organization. The candidate will work with regional and local teams to support development and implementation of a sourcing strategy at a global level, leveraging a Supply Strategy Council framework, while leading key initiative. In addition, the candidate will be responsible to establish and lead cross-functional teams through the sourcing process and to provide strategy oversight for regional and/or local components of the category. Day-to-day responsibilities of this role include identifying and managing key priorities: value creation, service delivery, foster innovation & digitalization & corporate social environmental responsibility. This individual requires a service mindset. In addition, this role is responsible and accountable for sustaining existing and developing new cooperation frameworks across three stakeholder groups: <ul><li> With Procurement Colleagues: Participates/leads teams of global, regional & local representatives to develop and implement strategic source plans as well as to ensure alignment on key initiatives and priorities for broader Marketing services categories. Act as a member of the team willing to carry out the mission and ensure that input from all members is taken into consideration. </li><li> With Business Partners: Identifies and engages with critical stakeholders and partners to define and meet or exceed business requirements and identify and manage profit plan savings targets. Understands strategic business requirements at 1,3 & 5year horizon. Acts as a trusted advisor to a wide range of business partners in the Marketing organization with a keen ear for needs and wants, and the ability to influence and guide strategic decision making, but also the courage to appropriately challenge the status quo. </li><li> With Suppliers: Responsible for building relationships with Global, International and Enterprise suppliers and managing key supplier performance against business requirements using proven processes; ensures adequate inclusion of diversity suppliers in RFPs and contracts as applicable. Supports major regional supplier relationships. Acts as a representative of the Corporation with a relentless drive to ensure our Company is using Supplier's core competencies, provides a fair opportunity for sustainable growth, and optimizes the spend. </li></ul> Key activities are listed below. The degree and time dedicated to each of these activities will vary depending on the maturity of the category and the strength and level of trust acquired with both suppliers and business partners. Strategy Creation Target : Definition and planning of high-level objectives targeted to long term results that will impact the way our Company views and purchases this category. This is the "big picture" creation and it entails active engagement with senior stakeholders as well as critical members of the business in the category during the course of Sourcing Management Process. Typical Activities : Meetings with stakeholders to discuss Sourcing Management Process strategic tools; participation in workshops and meetings during Sourcing Management Process; dialogue and meetings with Global Procurement in connection with Target; participation in Market Intelligence activities in connection with Target; data gathering and analysis in connection with Target; others that contribute to fundamentally change or effect the status quo in pursuit of a long-term competitive advantage to our Company. Strategy Execution Target : Implementation of tactical plans or projects directly linked to a strategy created during the course of Sourcing. Typical Activities : Development, rollout and execution of RFIs/RFPs pursuant to supplier selection aligned with strategic goals; process re-engineering in cooperation with the business pursuant to modify or create processes in connection with strategic goals; dialogue and meetings with Global Procurement in connection with execution of strategic goals; others that are directly linked with execution of strategic goals. Operations Target : Drive ongoing procurement activities pursuant to transactions and projects not in connection with Sourcing Management Process or strategy creation/execution. This is the "keep the lights on" and it is normally driven by daily/weekly requests from the business and procurement. Typical Activities : Contract review/negotiations; PO issue resolution; creation of new vendors; supplier issue resolution; technology/process execution; dialogues and meetings with Global Procurement in connection with supplier and stakeholder resolution; data gathering and analysis leading to short/medium term insights not in connection with Sourcing Management Process or strategy creation/execution; all transactions not in connection with Sourcing Management Process or strategy creation/execution which ensure sustainability of the procurement function. Supplier Relationship Management Target : Design, planning and implementation of actions and projects in connection with Sourcing Management Process or strategic goals pursuant to develop, improve, sustain or reposition our Company's relationship with critical/strategic suppliers. Typical Activities : Development/participation in supplier forums, congresses or market organizations; dialogues and meetings with business partners and suppliers in connection with Target; review, analysis and negotiation of contracts pursuant to Target; data gathering/analysis pursuant to generation of insights in connection with Target. Our Company's Leadership Standards applicable to the role includes: <ul><li> Make Rapid, Disciplined Decisions - Make timely decisions at the right level with the right data and support them once made. </li><li> Act with Courage & Candor - Speak openly, honestly and with conviction: have the courage to take appropriate risks and make difficult decisions. </li><li> Demonstrate Ethics & Integrity - Adhere to the highest standards of trustworthy and ethical behavior in all interactions and hold others to the same standards; comply with all laws, policies, and regulations; identify and address ethical issues without hesitation. </li><li> Foster Collaboration - Actively listen and seek to understand differing perspectives; work together to achieve the common goals of our Company. </li><li> Drive Results - Set clear performance standards; overcome obstacles; hold we and others accountable for achieving results. </li></ul> Education: <ul><li> Bachelor's degree in supply chain, procurement, business administration. </li></ul> Required Experience and Skills: <ul><li> Minimum of 5 years in strategic procurement, creative agency procurement, marketing or related role. </li><li> Must have strong experience in digital production and publication working with various operational and commercial models. </li><li> Strong analytical skills. </li><li> In-depth subject matter expertise in the creative and production agencies or sourcing field and current in industry trends and best practices. </li><li> Proven success in developing and executing global or regional creative sourcing strategies. </li><li> Strong communications and influencing skills at senior levels. </li><li> Proven ability to collaborate with a wide variety of individuals, including senior management, stakeholders, team members, other departments and suppliers. </li><li> Proven ability to effectively prioritize and execute tasks in a dynamic environment Preferred. </li></ul> Preferred Experience and Skills: <ul><li> Negotiating with creative/digital/marketing agencies of record. </li><li> Advanced Microsoft Office suite experience. </li><li> Knowledge of Decideware </li><li> Knowledge of procurement sourcing tools. </li><li> Knowledge of analytic dashboards. </li></ul>Required Skills: Business Decisions, Business Decisions, Clinical Supply Chain Management, Commercial Contract Negotiations, Corporate Social Responsibility (CSR), Cost Reduction, Creative Sourcing, Driving Continuous Improvement, Ethical Practices, Global Mindset, Inventory Control Management, Logistics, Logistics Management, Management Process, Manufacturing Sourcing, Negotiation, Operational Procurement, People Leadership, Procurement, Production Planning, Project Procurement Management, Strategic Procurement, Strategic Procurement Planning, Strategic Sourcing, Supplier Improvement {+ 5 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $126,500.00 - $199,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/4/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R371228

Associate Director - Creative Procurement

Job Description Field Access Manager The Field Access Manager (FAM) serves as the subject-matter expert on access related issues for healthcare professionals (HCPs) and healthcare organizations (HCOs), and will work cross-functionally with patient support, market access, and field sales to support timely patient access to therapy. The FAM will provide information to providers on access processes, reimbursement issues, and support patient assistance programs, all while ensuring compliance with healthcare regulations. The FAM role is a remote/field-based role that proactively provides approved education to defined accounts within an assigned geography on matters related to access and coverage to facilitate appropriate patient access. The FAM will analyze access issues and act as the local access resource for HCPs and other field force personnel and region management, as permitted by policy. Where appropriate, the FAM will coordinate with the access hub concerning individual patient cases including patient access and coverage assistance, hub enrollment and overall coordination. The FAM will need to collaborate cross functionally with Field Sales, Marketing, Market Access, Public Affairs, State and Government Affairs, Trade and Specialty Pharmacy Accounts while abiding by all corporate and industry policy and procedures. Joining this team means being a part of driving meaningful patient impact by utilizing our scientific expertise and serving as the primary contact for customers within your assigned territory: Louisville KY, Lexington KY, Evansville IN The FAMs will manage daily activities that support appropriate patient access. Activities include, but are not limited to: &bull; Provide information and/or education to HCP accounts on patient access, including benefit verification, prior authorization process, appeals process, and patient support programs in both live and virtual formats &bull; Analyze access trends &bull; Partner cross-functionally to identify and address barriers to patient access and supporting patient satisfaction &bull; Build collaborative, trusted relationships with internal stakeholders to support seamless patient access to therapy &bull; Monitor payer trends to address access barriers &bull; Provide access information to HCP offices &bull; Provide access education to field teams upon approved direction. &bull; Escalate and coordinate on access issues with third parties including hub vendor &bull; Provide education and support on Specialty Pharmacy issues &bull; Provide information to HCP offices on how the products are covered under the benefit design (Commercial, Medicare, Medicaid) &bull; Answer questions about coverage, including payer-specific access questions &bull; Maintain deep knowledge of regional and national market dynamics, and payer coverage policies. &bull; Act as a subject matter expert on access and affordability challenges across various payer types, including Medicare, Medicaid, and commercial plans &bull; Educate and update HCPs on key private and public payer coverage and changes that impact access for patients &bull; Support patient access to the product by providing subject matter expertise on payer coverage issues impacting product access in a manner that complies with policies, processes and standard operating procedures &bull; Educate HCP offices on the product hub program including, e.g., patient support offerings, financial assistance and hub educational resources &bull; Demonstrate knowledge of and communicate information about access resources and payer processes/policies &bull; Attend National and Regional Meetings Minimum Requirements: &bull; Bachelor's Degree; 7+ years' experience in patient support, healthcare sales or operations, project management, or reimbursement support &bull; Strong knowledge of health insurance structures (Medicare Part B, Medicaid, commercial) and related access processes, including benefit verification, prior authorization, and appeal processes &bull; Expertise in pharmaceutical compliance and HIPAA regulations regarding patient confidentiality &bull; Excellent interpersonal and communication skills; demonstrated ability to engage and influence diverse stakeholders across teams and disciplines &bull; Exhibit competent understanding of hub and patient support activities &bull; Proven ability to manage multiple priorities in a hybrid environment with 20-25% travel; Must reside in the assigned territory/metro area &bull; Ability to operate as a team player" in collaborating with multiple sales representatives, sales leadership, and internal colleagues appropriately to reach common goals &bull; Must be at least 21 years old with a valid driver's license and a clean driving record Preferred Requirements: &bull; Pharmaceutical industry experience highly preferred &bull; Deep understanding of HCP office workflows, prescription flow, and clinic operations; pulmonology experience preferred respsales Required Skills: Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $114,700.00 - $180,500.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 75% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/1/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R375944

Field Access Manager - Kentucky - Louisville KY, Lexington KY, Evansville IN

Job Description The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full Company's Research and Development Division portfolio of clinical trials. GCS is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities associated with clinical supplies for their assigned studies, which could vary in complexity. This individual serves as the primary GCS point of contact to stakeholders both internal and external to GCS and serves as the GCS spokesperson at clinical development related meetings (i.e., Clinical Trial Teams) and product development related meetings. The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (i.e. clinical development, CMC, supply chain, & human health), and balancing needs of patients & ensuring stable supply of product. Primary activities include, but are not limited to: <ul><li> Participates as a key stakeholder on the Clinical Trial Teams (CTT) and collaborates closely with other functional area representatives to negotiate timelines and strategy for clinical supplies. </li><li> Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical supply and/or change management related topics. </li><li> Responsible and accountable for establishing the timelines for clinical supply needs per study and providing the signal for sourcing, manufacturing, packaging, and distribution for the Company development products and non-Company marketed products. </li><li> Analyzes and anticipates project risks as they relate to clinical supply chain deliverables and prepares, analyses, and/or develops mitigation strategies for review with clinical partners and senior leaders. </li><li> Works directly in the SAP system to establish a consolidated, visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods). </li><li> Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation to support critical CMC activities. </li><li> Responsible for authoring the Clinical Supplies section of the study protocol as well as preparation and presentation of the clinical supplies information at Investigator Meetings for assigned protocols. </li><li> Support the collection of clinical supply chain metrics and/or participate in critical non-pipeline activities. </li><li> Participate in Interactive Voice Response (IVR) System development and User Acceptance Testing (UAT) for assigned studies. </li><li> Utilization of key technological tools and systems for GCS planning such as SWMS, Veeva, MEDS, MyLearning, SAP and Microsoft Applications and PowerApps. </li><li> Change Control Processing. Effective collaboration within GCS Planning and the Comparator Planning team to ensure that Change Requests are created and moved through the process steps in an efficient way, in accordance with established GCS planning SOPs/BPs and QMS Topic 3.4 Change Control Procedures and Work Instructions. </li><li> Mentors new team members and supports staff development, as needed </li><li> Demonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence portfolio decisions with facts and data </li><li> Demonstrates ability to balance strategy with ability for tactical execution and has strong ownership & accountability of assigned work </li><li> Focus on Customers & Patients. </li><li> Make rapid, disciplined decisions. </li><li> Demonstrates Ethics & Integrity. </li></ul> Required Experience and Skills: <ul><li> Bachelor's Degree in scientific, business, or related discipline required. </li><li> At least 5 years of experience in project management </li><li> At least 5 years of experience in planning, scheduling, coordination and processing of supply chain activities, or the equivalent </li><li> Excellent Communication & Interpersonal Skills: ability to effectively communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong negotiation, influencing, and relationship-building skills to ensure alignment and collaboration in the supply planning process. </li><li> Project Management Skills: strong knowledge of the principles of project management and clinical customer relationship management. </li><li> Technical Proficiency: familiarity with supply chain systems and software (e.g. SAP or Oracle) and demand planning principles as well as Microsoft Excel, PowerPoint, and Word </li><li> Strong Analytical & Problem Solving Skills: ability to analyze complex data, identify trends, and make data-driven decisions to optimize supply chain processes. </li><li> Flexibility & Adaptability: Demonstrates ability to thrive in a fast-paced and dynamic environment, with the capability to adapt quickly to changing business needs and priorities. </li><li> Detail Oriented & Organized: strong attention to detail in managing complex supply chain activities; ability to multitask, prioritize tasks, and meet tight deadlines. </li><li> Continuous Improvement Mindset: Proactive approach to identify process inefficiencies, develop solutions, and drive continuous improvement initiatives within the clinical supply planning function. </li><li> Proficiency in using supply chain management systems and software, including experience with ERP systems (e.g., SAP), demand planning tools, and inventory management systems. </li><li> Proven record in project / portfolio management. </li><li> Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) is highly desirable. </li></ul> Preferred Experience and Skills: <ul><li> Results-orientation with the proven ability to execute on collaborative projects and develop subject matter expertise </li><li> Knowledge of order management, supply chain operations and document control </li></ul> #eligibleforERP GCScareers GCScareer25 #PSCS #VETJOBS Required Skills: Adaptability, Adaptability, Change Control Processes, Change Management, Clinical Development, Clinical Documentation, Clinical Supplies Management, Clinical Supply Chain Management, Clinical Trial Management, Clinical Trials, Cross-Functional Team Leadership, Data Analysis, Demand Planning, Detail-Oriented, Good Manufacturing Practices (GMP), Interactive Voice Response (IVR), Interpersonal Relationships, Inventory Control System, Key Performance Indicators (KPI), Logistics, Materials Requirements Planning (MRP), Portfolio Management, Procurement, Project Management, Project Portfolio Management (PPM) {+ 5 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $114,700.00 - $180,500.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 12/20/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R370871

Sr. Specialist, Clinical Supplies Project Manager - Protocol (Hybrid)

Job Description Be a part of the legacy: Postdoctoral Research Fellow Program Our Research Laboratories' Postdoctoral Research Fellow Program aims to be a best-in-industry program for industrial postdoctoral researchers, designed to provide you with an academic focus in a commercial environment. With the resources, reach, and expertise of a large pharmaceutical company, postdoctoral researchers will be positioned to excel in an institution committed to breakthrough innovation in research and discovery. Position Overview: This position is in the vaccine modeling team of the Health Economic and Decision Sciences (HEDS) department withing Biostatistics and Research Decision Sciences (BARDS) at our Research Laboratories. BARDS HEDS provides strategic and analytic modeling expertise to measure and quantify the value of our company's products. As part of an agile team, the fellow will develop and support a seamless mechanism of coordination and collaboration in a dynamic area of interdisciplinary research. Collaboration with modeling scientists, data scientists, IT partners, subject matter experts and strategically leveraging generative AI to automate model extraction and facilitate rapid, intelligent adaptation across diverse settings, this project will profoundly enhance model transparency, dramatically accelerate deployment, and improve consistency in global health decision-making. This innovative approach promises to transform the efficiency and impact of health economic evaluations in infectious disease preparedness and response. At BARDS, we value diversity and inclusion in our working environment where employees are enabled to develop and contribute. Responsibilities include but are not limited to: Reporting under a Senior Director within the Vaccines team within HEDS, the fellow is expected to:<ul><li>Build a robust corpus of health economic infectious disease models using AI-assisted systematic review techniques,</li><li>Utilize advanced LLMs to precisely extract infectious disease model type, structure (states, transitions), and parameters (costs, utilities, probabilities),</li><li>Implement an intelligent AI reasoning layer to evaluate consistency, completeness, and scientific validity across extracted models,</li><li>Employ generative AI to propose new model structures, dynamically guided by disease-specific needs and prior evidence,</li><li> Apply the developed pipeline to critical case studies (e.g., RSV vaccine modeling) and rigorously compare AI-generated models with existing approaches, </li><li>Develop excellent working relationships within partner across our Research Laboratories; ensure effective cross-functional collaboration across teams,</li><li>Collaborate externally and solicit input from appropriate stakeholders and adopt latest techniques from relevant published literature, and</li><li>Disseminate key research findings/methodology via scientific presentations at congresses and publications in scientific journals.</li></ul>Education Minimum Requirement: Candidates should currently hold a PhD OR will receive a PhD by start of employment in Computer Science, Mathematics, Statistics, or a closely-related quantitative field. Required Experience and Skills:<ul><li>Previous experience with large language models (LLMs), natural language processing (NLP), or machine learning,</li><li>Strong programming skills in Python and/or C++, with experience in model fitting, simulation, and data extraction workflows,</li><li>Previous experience working on interdisciplinary research projects and/or working within interdisciplinary teams,</li><li>Ability to gather, organize, and synthesize complex information in order to draw conclusions and make recommendations,</li><li>Strong creative problem solving skills,</li><li>Strong interpersonal, networking, presentation, and communication skills, and</li><li>Ability to communicate effectively in English in both verbal and written formats.</li></ul>Preferred Experience and Skills:<ul><li>Experience in prompt engineering, fine-tuning, or evaluating large language models, and</li><li>Previous experience of health economic modeling and cost-effectiveness analysis for infectious disease.</li></ul> postdoctoralopportunities Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $75,000.00-$86,000.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here. Required Skills: Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/5/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R375491

Associate Scientist, Postdoctoral Fellow - AI in Infectious Disease Modeling

Job Description The Site Analytical Sciences Specialist role is responsible for supporting Analytical Procedure Life Cycle through end-to-end method lifecycle management including introduction of new analytical methods, analytical transfers, SME assessment for all analytical method & equipment performance qualification, investigations, product testing and technical rationale. This work will support pipeline and commercial products by utilizing expertise in the analytical areas of separations, biochemistry, and microbiology. This role requires 2nd shift hours in supporting the West Point Laboratory Operations. Activities Within Role: Technical expertise to support: <ul><li>New method introduction (Validation /Tech Transfer).</li><li>New technology introduction.</li></ul>Assessment and implementation of changes for existing methods and equipment: <ul><li>Change in technical element of method e.g. Parameter change</li><li>Change in equipment element of method e.g., column/reagent change.</li><li>Method troubleshooting where cross-functional investigation is required.</li><li>Technical SME for regulatory questions, audit support, reagent changes / supply issues to provided justification / rationale for analytical methods and equipment.</li><li>Technical review of impact on Analytical methods and equipment as part of cross-functional team assessment of new/revised Global Test method / Compendia changes or updates.</li><li>Management of PQ aspect of equipment qualification for all Quality Equipment, support IQ and OQ as required as part of capital projects.</li><li>Analytical equipment troubleshooting.</li><li>Initial training of end users in QC and Manufacturing and training of site analytical sciences personnel on lab systems, processes and methods where agreed.</li><li>Investigation lead/support for lab investigations.</li><li>Investigation lead for non-execution related investigations.</li><li>Authoring technical documentation in support of investigation and regulatory responses.</li><li>Analytical impact assessors on all QC Lab OPS change controls.</li><li>Technical Impact Assessment of proposed and finalized compendial changes.</li><li>Development and ownership of change control for new analytical methods.</li><li>Routine Assay Monitoring and lifecycle management of analytical methods.</li><li>Supporting digital method development.</li></ul>Continuous Improvements:<ul><li>Responsible for driving a culture of Continuous Improvement by deploying company Six Sigma tools.</li></ul>Coaching and Training:<ul><li>The Analytical Sciences Team Lead will provide support, guidance, and expertise to ensure the success of the Analytical Sciences group; will model the company Leadership behaviors and understand the MPS principles to drive a culture of continuous improvement building a High-Performance Organization.</li></ul> This position will report to the Site Analytical Sciences Lead. Education:<ul><li>Minimum education - Bachelors Degree in Biology, Chemistry, Engineering or related field.</li></ul>Required Skills: Adaptability, Adaptability, Analytical Instrumentation, Analytical Method Development, Assay, Behavioral Coaching, Biochemical Assays, Capital Projects, Cell-Based Assays, Dissolution Testing, Driving Continuous Improvement, GMP Compliance, Karl Fischer Titrations, Laboratory Documentation, Laboratory Safety, Microbiological Analysis, Microbiological Test, Microbiology, Molecular Microbiology, Reagent, Reagent Preparation, Software Documentation, Teamwork, Technical Specification Writing, Technical Writing {+ 1 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". The salary range for this role is $85,600.00 - $134,800.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): BSL2 Job Posting End Date: 12/27/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R369080

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