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This position will assist in preparing, editing and managing documents, reports, and presentations. Maintain and organize office files and records. Respond to inquiries via email, telephone, or in-person. Coordinate communication between NMAC Manager, NG911 Program Director and other departments. Schedule and coordinate meetings, appointments, and travel arrangements. Take minutes during meetings when needed. Provide administrative support to the NG 911 staff and other NC 911 staff. Maintain office supplies and equipment. Accounting responsibilities to be assigned. Process and distribute incoming and outgoing mail. Assist with special projects and research as needed. High level Excel experience is a requirement. The work schedule for this position is Monday through Friday, 8 a.m. - 5 p.m. This position is physically located on Wake Forest Road in Raleigh, North Carolina. This is not a remote or hybrid position. Knowledge, Skills and Abilities / Competencies Qualified applicants must submit an application that clearly reflects work experience that demonstrates the following: • Experience with Microsoft Office using programs such as Word, Excel and PowerPoint. • Experience in utilizing office equipment (such as printers, copiers, and fax machines) and other relevant technology (software and systems) to meet organizational needs. • Demonstrated previous experience in an office environment performing administrative duties. • Exceptional Phone/communication presence and ability to conference callers with Tier I and Tier II to provide support or open a bridge for a larger audience. • Basic knowledge on information handling policies and procedures. • Basic knowledge of document preparation, editing and management. • Ability to maintain and organize office files and records. Rename and save documents to maintain an organized file structure. • High school diploma or General Educational Development (GED) diploma and four years of related administrative experience; or • Equivalent combination of education and experience.

public

Administrative Assistant

Job DescriptionThe Program Specialist is responsible for serving as the customer’s primary point of contact providing operational and reimbursement support to complex programs within LabCorp, including, but not limited to, marketing support, reimbursement hotlines, patient assistance programs, Hubs, foundations, safety surveillance programs, case management, and compliance programs. The focus of the Program Specialist is to own issues and remove obstacles that prevent patients or providers from accessing the therapies requested. The Program Specialist will be a self-starter who is comfortable taking initiative, identifying barriers, and working with the appropriate parties to eliminate these obstructions for the customer. The Program Specialist is proficient and knowledgeable about all the services provided on an assigned program and may support multiple client products or programs. Lilly PAP Program  These RV PS will support Inbound calls supporting patients who are seeking approval for medications at no cost.  Inbound volume is expected to be high and agents will likely take back to back calls the majority of their shift.  Onboard training is the first two days (up to the first two and half days), anticipated training time for onboarding will be 8:00a-5p EST or 9:00 – 6p EST. Candidates will be assigned to the time that best corresponds with their location.  Program specific training duration is approximately 4 weeks. Candidates should not have PTO authorized during training period.  Please do not submit candidates that plan on having time off during the training period. Candidates should be available for the entirety of the training duration.  Additionally time off once training has been completed may be limited as well, this is a short term high volume project so we need all of the staff available to support the patients who need assistance.  Shift hours after training will be determined after training is completed but will fall during the Program's hours of operation: 8:00a-5:00p or 9:00-6:00 pm EST. Shifts are based on the needs of the business so they may change.&nbsp;Additional Skills &amp; QualificationsPreferred experience: 1. Major medical experience 2. Buy and bill experience 3. Specialty pharmacy 4. Acquisition channel experience 5. Customer service – 2 years healthcare NEEDED 6. Insurance benefits verification support 7. Call center previous experience - 1 year 8. Experience working remotely 9. Computer/technology experience 10. Strong communication skills

Customer Service Rep

This position is responsible for project set-up, monitoring the progress of the project and customer billing. This person will work closely with Project Managers and with customers ensuring the projects are completed on time. In addition to being able to proficiently perform all of the functions of a Contracting Project Administrator I, must be able to perform these additional duties:&nbsp;· Oversee large projects to ensure contract compliance and successful completion.&nbsp;· Must be capable of reviewing and understanding terms and conditions of large projects.&nbsp;· Assists with the accurate and timely recording of project costs.&nbsp;· Schedule and participate in internal project team meetings to ensure accurate transfer of information.&nbsp;· Ability to read and comprehend construction schedules.&nbsp;· Monitors and adjusts AIA schedule of values.&nbsp;· Provides assistance in forecasting of corporate revenue projection.&nbsp;· Communicate project concerns with Project Managers and legal staff.&nbsp;· Coordinates with various staff for accurate and timely recording of project costs, including time sheets, daily reports, etc.&nbsp;· Other duties as assigned.&nbsp;Additional Skills &amp; QualificationsMUST HAVE&nbsp;Bachelors Degree OR 2 yrs+ experience working in similar role&nbsp;Proficient with Microsoft Office products (Excel – Intermediate)&nbsp;Excellent communication skills (Verbal &amp; Written)&nbsp;&nbsp;NICE TO HAVE&nbsp;Experience in general accounting and a general knowledge of construction &amp; contract administration.

Project Coordinator

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. We believe the Greater Boston area is an important hub for the biotech and pharma industry, which is why we've invested in growing our footprint and expanding our R&D space in Cambridge, with a primary focus on additional state-of-the-art lab space. Here, we will bring together talent and expertise, building upon GSK's long history of vaccine development, to create globally leading viral capabilities and cutting-edge vaccines technologies, as we add to our robust portfolio targeting infectious diseases at every stage of life. In the plan to create a new hub for mRNA-based vaccine discovery in Cambridge, we are building new laboratories that will be focused on the development of state-of-the-art methods that will be supporting deep product understanding, process and product development, as well as testing of pre-clinical and clinical samples for new mRNA-based vaccines. As a Principal Scientist, you will be expected to lead, design and execute scientific studies in support of technical programs as they progress from development into early clinical Phases. You will also ensure implementation of innovative and cutting-edge analytical methods and technologies for mRNA and macromolecule (proteins) characterization and testing in line with Quality by Design (QbD) principles in the area of Phys-Chem and Separation technologies (including and not limited to MS, Chromatography, Electrophoresis, Spectroscopy analyses and techniques used to characterize macromolecules, (e.g. mRNA and proteins, at molecular level)). As a PrincipalScientist, you will participate in experimental activities according to defined priorities and will be responsible for the quality of data and presentation of results to internal and external audiences. The successful applicant will spend 3-6 months within the first year in Rockville, MD to support and guarantee a smooth transition of methods and know-how to the new laboratories in Cambridge, MA. Key Responsibilities: <ul><li>Is independently responsible for the conception, design, implementation of analytical methods and interpretation of scientific and technical data to support projects.</li><li>Design and lead specific development workstreams autonomously, in line with business priorities, following the Quality by Design framework.</li><li>Function effectively as a core team member on multiple concurrent project workstreams and established work processes.</li><li>Solve complex problems through collaborations with others (inside ARD, within Technical RD, with Preclinical and outside GSK), taking a new perspective on existing solutions.</li><li>Generate strong relationships in the area of technical development with high quality partners beneficial to the organization, both internally and externally (inside ARD, within Technical RD, with Preclinical and outside GSK), to strengthen development/ implementation of new methods/technologies, with a specific focus in the preclinical interface.</li><li>Participate and lead the transfer of developed analytical methods within ARD groups (different sites) or other external partners. Analyse, interpret and communicate scientific data effectively within Technical R&D including Technical Development Team and be able to defend scientific and technical decisions at the appropriate technical board.</li><li>Utilize technical process knowledge to meet regulatory requirements appropriate for stage of development.</li><li>Author and review technical documents in support of various project development stages.</li><li>Make sound scientific/technical and business decisions based on a balance of data, analysis and experience.</li><li>Benchmark specific technologies in own functional area to bring innovation and technology to state of the art. Identify opportunities to apply new techniques to address project challenges.</li><li>Contribute and drive strategy and technical development planning and accountability in the execution thereof.</li><li>Collaborate with scientific staff, provide guidance to new team members and act as a resource for colleagues with less experience.</li><li>Lead and implement GxP / EHS / QA rules application.</li><li>Ensure toxicology and development testing and stability are executed with respect to deadlines and in compliance with the expected requirements.</li><li>May represent GSK externally in conferences.</li><li>Act as a voice and ambassador of its department at various internal and external governance bodies and meetings.</li></ul> Basic Qualifications: <ul><li>Degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related scientific field.</li><li>PhD with 3+ years of post-doc and/or job-related experience, MS with 6+ years of experience, or BS with 9+ years of experience. </li></ul> Preferred Qualifications: <ul><li>Expert knowledge in Mass Spectroscopy, Chromatography, HPLC, Electrophoresis, Spectroscopy analyses and techniques used to characterize macromolecules, e.g. mRNA and proteins, at molecular level.</li><li>Good understanding of QbD principles.</li><li>A good understanding of biopharma / vaccine development process.</li><li>Has worked in a multi-disciplinary team, demonstrates skills in combining different physico-chem and separation analytical technologies in the field.</li><li>Total education and experience in biopharma-related domain of at least 8 years.</li></ul>#Vx-Cam #Li-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Principal Scientist mRNA (Mass Spectrometry)

Site Name: USA - Massachusetts - Cambridge, Belgium-Rixensart, Italy - Siena Posted Date: Aug 20 2024 This role could be based in Rixensart Belgium, Siena Italy or Cambridge, MA US and requires a 3 day minimum on-site presence. The Global Head of Lab Systems & Automation is accountable for the strategy and global end-to-end lifecycle management of Vaccines R&D laboratory computerized systems, including robotics and automation solutions. This role provides strong leadership, strategic direction, and focus to implement and maintain automated and/or computerized systems & applications in an ever-changing environment in terms of GSK Vaccines' growth profile, laboratory science innovation, regulatory requirements, and quality/EHS standards. The Global Head of Lab Systems & Automation plays a pivotal role in supporting the organization in generating high quality structured data to drive our R&D projects forward. This role is focused on strong collaboration between Tech, Digital & Data, and Quality - applying business acumen, deep technical experience in laboratory instrumentation & automation, and process knowledge to drive innovative, pragmatic solutions for Vaccines R&D Scientists. The Global Head of Lab Systems & Automation will act as the Operational Technology (OT) Officer for Vaccines R&D ensuring that OT risk is appropriately assessed, prioritized, and mitigated across Vaccines R&D. This role will ensure that centrally defined OT security standards and controls are appropriately considered and adopted / adapted in the labs and is accountable for OT cybersecurity controls and compliance. Key Responsibilities: This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following. Leadership<ul><li>With strategic vision, guides the Lab Systems & Automation organization, partners, and customers to deliver innovative solutions for Vaccines R&D's Scientists. Promote advancement of automation systems through a focus on automation innovation to drive scientific/business process improvement and the generation of high-quality structured data.</li><li>Leads country-based Lab Systems and Automation teams ensuring business-as-usual lifecycle management support for Vaccines R&D lab systems; appropriate planning, resourcing, and successful execution of multiple operational/innovation projects conducted in parallel with business-as-usual operations.</li><li>Drive employee engagement within the global Lab Systems & Automation team with emphasis on people development, enriching roles, effective recognition, and open & honest conversations.</li><li>Play a leadership role to ensure standards, policies, and procedures are fit-for-purpose (e.g. Computer System Validation, Data Integrity, OT design / cybersecurity risk assessments & mitigations).</li></ul>Stakeholder Management<ul><li>Work in partnership with a broad range of stakeholder groups including the R&D scientific functions as well as Tech, Computer System Validation, and Quality to define and implement fit-for-purpose system solutions to optimize the value of lab equipment and the productivity of Scientists.</li><li>Proactively define lab automation technology standards, identify process improvement/cost saving opportunities, and accelerate generation of scientific results.</li><li>Application of agile methodology to quickly respond and deliver in a fast pace changing environment.</li><li>Manage, coordinate, supervise external partners throughput the entire systems lifecycle.</li><li>Maximizing investment value for GSK while negotiating with external partners.</li><li>Liaise with other GSK sites / orgs as well as external companies on benchmarks and best practices.</li><li>Liaises with stakeholders across the Vaccines R&D sites (Belgium, Italy, US) and with Pharma R&D to promote leveraging of technology, systems/applications, and automated solutions between functions and sites.</li></ul>OT Officer responsibilities<ul><li>Vaccines R&D representative at the R&D OT Operations Forum and Data Governance Risk Council</li></ul><ul><li>OT Cybersecurity Risk Assessment and Compensation Process: <ul><li>Responsible for carrying out risk assessments with respect to OT cybersecurity across the business area and managing the risk compensation process.</li><li>Understand new threats, the potential for business impact and how GSK will respond via our cybersecurity standards and controls.</li><li>Appropriate risk escalation of any issues and exceptions in accordance with the R&D OT Cybersecurity escalation process</li></ul></li></ul><ul><li>Risk Mitigation:<ul><li>Feed critical deliverables into VxRD Digital and Data Strategy to drive investment</li><li>Collaborate with R&D Digital & Tech and Central Tech, including the Cybersecurity Office (CSO), and Global Products & Technology (GP&T) stakeholders to ensure the controls proposed to mitigate risks are appropriate for the business area, correctly implemented and adopted consistently.</li><li>Review and approval of Firewall (FW) rules, reference architecture, VLAN strategy and high-level strategy for local deployment.</li><li>Understand and action on OT vulnerabilities and crisis management, OT alerts, OT responses and recovery processes</li></ul></li></ul><ul><li>Cybersecurity Technical expertise and Business Analysis:</li><li>Actively participate in and provide business input into the design, documentation, implementation and continued support of OT cybersecurity standards and associated tools (e.g., access management tool) and controls, including maintenance of the controls and their associated documentation post deployment.</li><li>In collaboration with GSK Tech, input into the design and documentation for Network Segmentation for the business area. </li><li>Application of GSK's cybersecurity standards is maintained across the laboratory environment (e.g. robust system inventory maintenance) and critical risks are escalated for remediation to the Risk Management Board and the Capital Allocation process.</li><li>Liaise with business line leaders, science, and engineering SMEs within the business area, in making cybersecurity decisions.</li><li>The role holder will play an active role in the OT Change Advisory Board (CAB) ensuring the business area's requirements and deliverables are adequately represented. This includes responsibility for review and approval of firewall (FW) rules, OT architecture, VLAN strategy and local deployment strategy.</li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li>Bachelor's degree in Business or Science, Engineering, Information Technology or related discipline</li><li>7+ years operational experience managing lab systems in validated and non-validated environments</li><li>3+ years line manager experience leading large multi-site and global teams</li><li>Experience with Stakeholder management - applying technical knowledge and lab systems</li><li>Experience partnering with the Tech organization to drive fit-for-purpose system solutions and reliable provision of service to Vaccines R&D</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li>Masters, PhD or MBA, or post-graduate professional qualification in Business or Science, Engineering, Information Technology related discipline</li><li>Ability to think strategically and act with a high level of integrity to establish effective plans of action to deal with conflicting issues in a manner consistent with GSK's global requirements</li><li>Ability to work with an agile methodology to quickly respond and deliver in a dynamic environment.</li><li>Change management strategies and implementation</li><li>Large technical program implementation experience</li><li>Demonstrated ability, when working under pressure, to decisively adjust a course of action in a rapidly changing and highly uncertain environment</li><li>Excellent verbal and written communication with strong presentation skills</li><li>Problem solving abilities suitable for handling the highly complex issues associated with cross organizational boundaries</li><li>Decision making and application of risk management principles</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Global Head of Lab Systems & Automation

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. We believe the Greater Boston area is an important hub for the biotech and pharma industry, which is why we've invested in growing our footprint and expanding our R&D space in Cambridge, with a primary focus on additional state-of-the-art lab space. Here, we will bring together talent and expertise, building upon GSK's long history of vaccine development, to create globally leading viral capabilities and cutting-edge vaccines technologies, as we add to our robust portfolio targeting infectious diseases at every stage of life. In the plan to create a new hub for mRNA-based vaccine discovery in Cambridge, we are building new laboratories that will be focused on the development of state-of-the-art methods that will be supporting deep product understanding, process and product development, as well as testing of pre-clinical and clinical samples for new mRNA-based vaccines. As a Principal Scientist, you will be expected to lead, design and execute scientific studies in support of technical programs as they progress from development into early clinical Phases. You will also ensure implementation of innovative and cutting-edge analytical methods and technologies for mRNA and macromolecule (proteins) characterization and testing in line with Quality by Design (QbD) principles in the area of Phys-Chem and Separation technologies (including and not limited to MS, Chromatography, Electrophoresis, Spectroscopy analyses and techniques used to characterize macromolecules, (e.g. mRNA and proteins, at molecular level)). As a Principal Scientist, you will participate in experimental activities according to defined priorities and will be responsible for the quality of data and presentation of results to internal and external audiences. The successful applicant will spend 3-6 months within the first year in Rockville, MD to support and guarantee a smooth transition of methods and know-how to the new laboratories in Cambridge, MA. Key Responsibilities: <ul><li>Is independently responsible for the conception, design, implementation of analytical methods and interpretation of scientific and technical data to support projects.</li><li>Design and lead specific development workstreams autonomously, in line with business priorities, following the Quality by Design framework.</li><li>Function effectively as a core team member on multiple concurrent project workstreams and established work processes.</li><li>Solve complex problems through collaborations with others (inside ARD, within Technical RD, with Preclinical and outside GSK), taking a new perspective on existing solutions.</li><li>Generate strong relationships in the area of technical development with high quality partners beneficial to the organization, both internally and externally (inside ARD, within Technical RD, with Preclinical and outside GSK), to strengthen development/ implementation of new methods/technologies, with a specific focus in the preclinical interface.</li><li>Participate and lead the transfer of developed analytical methods within ARD groups (different sites) or other external partners. Analyse, interpret and communicate scientific data effectively within Technical R&D including Technical Development Team and be able to defend scientific and technical decisions at the appropriate technical board.</li><li>Utilize technical process knowledge to meet regulatory requirements appropriate for stage of development.</li><li>Author and review technical documents in support of various project development stages.</li><li>Make sound scientific/technical and business decisions based on a balance of data, analysis and experience.</li><li>Benchmark specific technologies in own functional area to bring innovation and technology to state of the art. Identify opportunities to apply new techniques to address project challenges.</li><li>Contribute and drive strategy and technical development planning and accountability in the execution thereof.</li><li>Collaborate with scientific staff, provide guidance to new team members and act as a resource for colleagues with less experience.</li><li>Lead and implement GxP / EHS / QA rules application.</li><li>Ensure toxicology and development testing and stability are executed with respect to deadlines and in compliance with the expected requirements.</li><li>May represent GSK externally in conferences.</li><li>Act as a voice and ambassador of its department at various internal and external governance bodies and meetings.</li></ul> Basic Qualifications: <ul><li>Degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related scientific field.</li><li>PhD with 3+ years of post-doc and/or job-related experience, MS with 6+ years of experience, or BS with 9+ years of experience. </li></ul> Preferred Qualifications: <ul><li>Expert knowledge in Mass Spectroscopy, Chromatography, HPLC, Electrophoresis, Spectroscopy analyses and techniques used to characterize macromolecules, e.g. mRNA and proteins, at molecular level.</li><li>Good understanding of QbD principles.</li><li>A good understanding of biopharma / vaccine development process.</li><li>Has worked in a multi-disciplinary team, demonstrates skills in combining different physico-chem and separation analytical technologies in the field.</li><li>Total education and experience in biopharma-related domain of at least 8 years.</li></ul>#Vx-Cam #Li-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Principal Scientist mRNA (Physical Chemical Separations)

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. We believe the Greater Boston area is an important hub for the biotech and pharma industry, which is why we've invested in growing our footprint and expanding our R&D space in Cambridge, with a primary focus on additional state-of-the-art lab space. Here, we will bring together talent and expertise, building upon GSK's long history of vaccine development, to create globally leading viral capabilities and cutting-edge vaccines technologies, as we add to our robust portfolio targeting infectious diseases at every stage of life. The Nucleic Acid Vaccines Center of Excellence (NAV CoE), a global team within Drugs Substance Vaccines Technical Research and Development organization, has mission to develop next generation mRNA Drug Substance vaccine platforms for rapid development of new vaccine candidates. It has branches in Rockville, US (to be moved to Cambridge, US in Q2 2025) and in Rixensart, Belgium. We are seeking a Director to lead the NAV CoE, to be based in Cambridge. This senior leader in RNA technologies will be responsible for establishing the NAV CoE at its new Cambridge location, transferring current labs and team members from Rockville, recruiting top-tier scientists, and building a high-performing team to advance vaccine candidates from discovery and pre-clinical phases through the CMC roadmap. Additionally, the Head of NAV CoE will drive the development of innovative next-generation RNA technologies to maintain GSK's leading position in the industry. This role will report to the Global Head of CVDS (based in Belgium) and will play a significant role in shaping current and next generation GSK vaccine platforms to accelerate addressing unmet medical needs, a compelling field having a direct impact on patients and global health. This exciting opportunity will allow you to lead key activities, collaborate with top talents in the vaccines industry, and advance your career while ensuring timely project delivery in collaboration with process development colleagues and GMP teams. Key responsibilities: <ul><li>Leader of leaders: Lead a team of leaders heading platform development, analytical development and project delivery, based in Cambridge, MA and Belgium. This organization has the following missions:<ul><li>Delivery of new vaccine candidates using a full platform approach.</li><li>Evolve our current Drug Substance RNA vaccine platform through innovation & technology.</li><li>Onboard and develop alternative nucleic acid modalities & platforms to shape next generation vaccine technologies.</li></ul></li><li>Design and drive scientific strategy for vaccine early development phases and integrate it into the end-to-end CMC strategy. Collaborate closely with stakeholders to ensure timely delivery.</li><li>Build and Integrate a High-Performing global organization of leaders and top scientists, prioritizing people's development and integration into the global Drug Substance and broader R&D organization.</li><li>Cultivate department culture: Excellence in science and operations, embracing an open global mindset, fostering a positive culture of transparency and collaboration within the global organization.</li><li>Act as a key opinion leader: use critical thinking and strategic proficiency to ensure impact within DS, across functions and at senior leadership level to continuously improve and shape the CMC strategy & framework.</li></ul> The successful applicant will spend 3-6 months within the first year in Rockville, MD to support and guarantee a smooth transition of methods and know-how to the new laboratories in Cambridge, MA. Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>PhD in Molecular Biology, Biotechnology, Bioengineering, Chemical Engineering, or a related scientific field.</li><li>Three or more years of academic independent research in an environment related to mRNA science, technology, therapy and/or vaccines.</li><li>Five or more years of leadership experience in industry in an environment related to mRNA science, technology, therapy and/or vaccines.</li><li>Five or more years of experience leading a team.</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li>Knowledge of regulatory vaccine landscape FDA/ICH/ISPE.</li><li>Agile mindset fitting a CoE environment.</li><li>Strong ability in scientific and people leadership, and communication skills at senior level.</li><li>Strong ability in scientific and people leadership, and communication skills at senior level.</li><li>Comfortable challenging the status quo and letting the science leading the way.</li><li>Collaborative approach working comfortably in the global DS and vaccines networks across different cultural environments.</li><li>Great communication & interaction skills motivating a team of deep experts and scientist around common goals.</li></ul>#Li-GSK #Vx-Cam Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Director, Global Head of Nucleic Acid Vaccines CoE

A career in Boston - main video - YouTube At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. We believe the Greater Boston area is an important hub for the biotech and pharma industry, which is why we've invested in growing our footprint and expanding our R&D space in Cambridge, with a primary focus on additional state-of-the-art lab space. Here, we will bring together talent and expertise, building upon GSK's long history of vaccine development, to create globally leading viral capabilities and cutting-edge vaccines technologies, as we add to our robust portfolio targeting infectious diseases at every stage of life. The Mammalian Expression Technologies Center of Excellence (MET CoE) at GSK Vaccines is responsible for the generation of CHO-based production cell lines for the expression of innovative recombinant protein vaccines. The MET CoE is looking for a motivated scientist to support next-generation cell line engineering initiatives. Located in Cambridge, MA, the position will play a significant role in shaping current and next generation GSK's leading vaccine platforms to accelerate addressing unmet medical needs, an exciting field having a direct impact into patients and global health. This role provides the opportunity to integrate a diverse group of top talented experts in vaccines' industry, lead key activities and further grow and progress in your career. These activities will include: <ul><li> Design and develop omics-based screening strategies for discovery of novel gene targets in CHO cells. </li><li> Perform advanced NGS data analytics to elucidate key biological targets for next-generation CHO host evolution. </li><li> Stay up to date with the latest quality and regulatory guidance to support project documentation and accelerated CMC timelines. </li></ul> The successful applicant may spend 3-6 months within the first year of hire in Rockville, MD to support and guarantee a smooth transition of methods and know-how to the new laboratories in Cambridge, MA. Basic Qualifications: We are looking for professionals with these required skills to help us achieve our goals: <ul><li> PhD with 2+ years' industry experience in molecular biology, computational biology, genetics, or another relevant field. </li><li> Two or more years of experience with NGS techniques (wet and dry lab) and associated methodologies, including analyses of large datasets. </li><li> Two or more years of experience with the implementation of genome-scale modelling approaches to establish biological and mechanistic networks. </li></ul> Preferred Qualifications: The following skills are a plus for this role: <ul><li> Hands-on experience with mammalian cell culture, including clonal derivation and transfection. </li><li> Experience with genome-editing tools for mammalian cell engineering. </li><li> Deep understanding in CMC drug substance space as it relates to cell line development. </li></ul> #Vx-Cam #LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Principal Scientist, Cell Line Engineering

Site Name: USA - Massachusetts - Waltham Posted Date: Aug 30 2024 Accountable to GRL and Global Regulatory TA Head for development of appropriate regional regulatory strategy(s) and for delivery according to plans. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with at least the local regulatory agency. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile. Work closely with local / regional commercial team to secure best possible labelling commensurate with the available data. Lead interactions with local / regional regulatory authorities. Key Responsibilities:<ul><li>Proactively develop regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally. </li><li>Implement the regional strategy(s) in support of the project globally</li><li>Lead regulatory interactions and the review processes in local region</li><li>Ensure appropriate interaction with global/regional counterparts and commercial teams in local region</li><li>Ensure compliance with global/ regional requirements at all stages of product life</li><li>Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset.</li></ul>Basic Qualifications:<ul><li>BSc in Biological or Healthcare Science </li><li> Experience of all phases of the drug development process in regulatory affairs preferred </li><li>Experience with clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally.</li><li>Experience in relevant therapy area, and ability to further develop necessary specialist knowledge for the product or area of medicine</li></ul>Preferred Qualifications:<ul><li>PhD in Biological or Healthcare Science </li><li>Capable of leading regional development, submission and approval activities in local region(s) </li><li>Ability to foster strong matrix working. Facilitates dialogue between team and matrix members to contribute their ideas. Capable of developing and recommending strategies for change. </li><li>Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Seeks to raise levels of performance by establishing or improving process</li><li>Good communication skills, especially in writing. Capable of delivering key communications with clarity, impact and passion</li><li>Ideally good listening and comprehension skills; proactive in identifying potential issues and escalating them accordingly</li><li>Capable of identifying project or team issues in advance and seeking necessary help and support to resolve.</li><li>Ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Recognises potential long term issues for projects.</li><li>Ability to take sound decisions and in doing so, the job holder will use a range of sources and weight benefits and risks before making important decisions.</li><li>Developing personal networks, within GSK and capable of using them to secure appropriate support and outcome for a project. </li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Manager, Global Regulatory Affairs

Site Name: USA - Massachusetts - Waltham Posted Date: Sep 13 2024 We are seeking an Associate Director level, Quantitative Systems Pharmacology Lead for our Clinical Pharmacology Modelling and Simulation (CPMS) department. Quantitative Systems Pharmacology (QSP) is a discipline that uses mechanistic mathematical models and disease platforms to enhance the robustness and quality of decision-making from exploratory research through clinical development. We are seeking a highly motivated individual to develop and apply QSP models to guide clinical study designs and mechanistic interpretation of study results in support of development of treatments and combination of treatments for a variety of diseases and therapeutic areas. The successful candidate will be responsible for integrating and sharing data and knowledge in a highly stimulating, collaborative, and multi-disciplinary environment to influence clinical study decisions and develop a deeper understanding of physiological systems and disease mechanisms within oncology. A successful candidate comes with passion and curiosity and works collaboratively in multidisciplinary teams and with QSP modelers internally and externally. Role Responsibilities: This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following. <ul><li>Build and utilize QSP models of biological, physiological, and pathophysiological processes to evaluate a disease, its pathways and progression, as well as drug candidates or treatment modalities</li><li>Work in close collaboration with biologists, clinicians, clinical pharmacologists, pharmacometricians, QSP and nonclinical modelers, and other partner line colleagues to inform research and development programs and improve our understanding of disease mechanisms</li><li>Serve as QSP modeling & simulation point-of-contact in on project teams to solve challenging problems in drug research and development; contribute to preclinical and clinical study design and mechanistic interpretation of data</li><li>Develop and/or utilize state-of-the-art mathematical tools to gain insight into causal relationships between individual components of system-level and drug-level responses of drug-target-biomarker-disease-patient interaction</li><li>Analyze and interpret complex data sets in the context of disease mechanisms and pathways</li><li>Explore new QSP opportunities in combining QSP with other analytical approaches and build synergies through collaboration with computational groups including human genetics and functional genomics</li><li>Provide both scientific and strategic expertise in oncology therapeutic area to facilitate, develop and deliver quantitative support for decision making in clinical development programs</li><li>Perform scientific rigor and biological suitability assessment of QSP models and methodologies through establishing a context-driven verification & validation process (reviewing QSP model goals, assumptions, methodology, model code, model outputs, uncertainty quantification)</li></ul>CPMS is a science driven group delivering clinical pharmacology modelling & simulation excellence to research and development programs. We use quantitative pharmacology approaches, as part of the model-informed drug discovery & development paradigm (MID3), to evolve understanding of compound behavior and optimize dose across the research and development continuum, delivering a competitive label for a filing. Our activities include:<ul><li>Advise on dose, regimen and study design to optimize understanding of compound characteristics and variability in exposure and response across all drug development phases.</li><li>Provide insights to programs through mechanistic modeling of drug-target-biomarker-disease-patient interaction (QSP modeling)</li><li>Identify opportunities to re-use clinical data to extrapolate to untested scenarios, avoiding unnecessary additional clinical trials.</li></ul>Basic Qualifications: We are looking for professionals with these required skills to achieve our goals :<ul><li>PhD in Applied Mathematics, Engineering, Pharmaceutical Sciences, Systems Biology, or related disciplines with experience in the application of mathematical and statistical methods</li><li>2 or more years of experience in Pharma Life Science Biomedical industry developing and applying QSP approaches to drug development programs</li><li>Experience working with the theory, principles, statistical aspects of mathematical modeling and simulation, including numerical methods, parameter estimation/optimization, ordinary differential equations (ODEs), and how these can be applied in the development of complex models of biological pathways and systems</li><li>Computational experience with one or more modeling and simulation packages or programming languages (e.g., MATLAB, R, Julia, SimBiology, C/C++)</li><li>Experience working with common tools for quantitative clinical pharmacology (such as NONMEM, R, WINNONLIN, Simcyp, SAS)</li><li>Experience developing mechanistically-sound PK-PD models</li><li>Experience translating, condensing, summarizing outcomes of modeling and simulation analyses into information that can be understood by project teams</li></ul>Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li>Demonstrated collaborative ways of working and able to work successfully in matrix teams</li></ul><ul><li>Ability to effectively communicate and interact with key stakeholders, medical professionals and senior leadership</li><li>Ability to learn new areas of biological sciences and build on solid foundation of quantitative skills</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Associate Director, Quantitative Systems Pharmacology Lead

Site Name: USA - Connecticut - Branford Posted Date: Sep 12 2024 ViiV Healthcare is looking for a Scientific Leader to join the Discovery DMPK (drug metabolism and pharmacokinetic) team based in Branford CT as a Project Specialist focused on discovering new medicines for the treatment, prevention and cure of HIV. As an individual contributor, the DMPK Project Specialist ensures that our DMPK science is embedded in Discovery projects across all modalities (small and large molecule) from commit to target through Phase I clinical work, and is accountable for driving the translational understanding of drug disposition and pharmacokinetic-pharmacodynamic (PKPD) approaches for projects that may include both oral and long-acting injectable medicines. The role requires working within matrix teams to design, complete and interpret in vitro and in vivo ADME studies, providing DMPK strategic leadership to discovery project teams, and contributing to the overall direction of our DMPK science to ensure that innovation is aligned with portfolio deliverables. Finally, the role has a significant writing component to contribute to internal reports, technical evidence, ADME reports and regulatory documents (e.g., IND, Investigator's Brochure). This role will provide the opportunity to lead key activities and to progress your career. These responsibilities include:<ul><li>Drive the DMPK strategy for multiple Drug Discovery stage projects from early lead optimization through Phase I clinical studies.</li><li>Ensure that translational PKPD approaches and appropriate screening cascades with multi-parametric optimization are being applied to assigned projects.</li><li>Utilize your extensive laboratory experience to design and conduct/oversee bespoke mechanism-based studies to address program needs.</li><li>Efficiently manage your time and project requests for DMPK work to ensure optimal support of projects across different modalities in the ViiV Discovery pipeline.</li><li>Coordinate and deliver high-quality DMPK written contributions to technical and regulatory documents.</li><li>Develop and maintain excellent working relations with stakeholders in Discovery project teams, in order to ensure strategic alignment.</li><li>Actively support cross-DMPK initiatives as a representative from the ViiV Nonclinical Safety and DMPK team to drive DMPK science and operations.</li></ul> Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>MS Degree (7 years' experience) or PhD (>2 years' experience post graducation) in a field relevant to DMPK (e.g., Pharmacology, Biochemistry, Pharmacokinetics or Drug Metabolism)</li><li>Experience state-of-the-art DMPK science in projects to enable the discovery of new medicines, including experience with small molecules and biologics drug discovery and/or development.</li><li>Experience managing DMPK related project resources and budgets.</li><li>Experience working in cross-matrix teams, with demonstrated experience in project milestone delivery.</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li>PhD in a field relevant to DMPK (e.g., Pharmacology, Biochemistry, Pharmacokinetics or Drug Metabolism) with >5 years drug discovery experience.</li><li>In-depth experience in DMPK representation in Discovery projects across different modalities (e.g., small molecule, mAb, long-acting injectable) and has strong experience in human dose prediction.</li><li>Examples demonstrating the successful selection of drug candidates through efficient ADME screening cascades such as multi-parametric optimization, translational PKPD and human dose optimization strategies.</li><li>Experience in leveraging modeling approaches and predictive science in Discovery projects to accelerate timelines and increase probability of success.</li><li>Excellent communication/written skills and collaboration as demonstrated through publication and/or external interactions (e.g., university collaborations, speaking invitations etc.).</li></ul>#LI-GSK #LI-ViiV Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program ViiV offers US employees. All ViiV employees receive the same benefits options and plans as GSK employee. Why Us? At ViiV Healthcare, we will not rest until we leave no person living with HIV behind. Until the 39 million people living with HIV is down to zero, we will continue searching for new ways to limit the impact of HIV. We are the only pharmaceutical company solely focused on combating, preventing, and ultimately eradicating HIV and AIDS. At ViiV Healthcare, we do things differently. Born out of a partnership between GSK and Pfizer in 2009, with Shionogi joining in 2012, we are determined to help end the HIV epidemic. We are guided by our mission to leave no person living with HIV behind and it is this mission that unites our employees located across the globe. We combine expertise in research, manufacturing, policy and more to push the boundaries of what people think is possible in HIV treatment and care. As a result of our connection with GSK, we are able to draw on their proud history and resources. This means that you would receive all the employee benefits offered by GSK. Living our mission of leaving no person living with HIV behind means keeping inclusion and diversity at the heart of everything we do - from our breakthrough innovation, to our diverse portfolio of medicines as well as the work we do to partner with HIV communities. Having a diverse team and a truly inclusive culture where we're all able to be ourselves and feel like we belong will make us an even stronger team, better able to perform as a business and deliver on our mission to leave no person living with HIV behind. If you require an accommodation or other assistance to apply for a job at ViiV, please contact the ViiV Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). ViiV is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies ViiV does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact ViiV's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and ViiV. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ViiV. ViiV shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, ViiV may be required to capture and report expenses ViiV incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure ViiV's compliance to all federal and state US Transparency requirements. For more information, please visit ViiV's Transparency Reporting For the Record site.

ViiV Scientific Leader

Site Name: Home Worker - USA Posted Date: Sep 9 2024 Are you energized by a role that will develop strategy of value communication content supporting key pipeline Oncology products? If so If so, this career opportunity could be an ideal opportunity to explore. The Director, Strategy & Value Communications - Oncology serves as the accountable medical lead for developing overall strategy and delivery of value communication content for engaging population-based decision makers (PBDM) supporting GSK's marketed and pipeline oncology products. This position reports to the Head of Medical Accounts and works in close collaboration with our Field Medical Account Leads (FMALs), medical therapeutic area/matrix partners including value evidence and outcomes and commercial market access/brand strategy teams. You will represent the medical needs of key PBDM customers (e.g. Payers, specialty pharmacy, GPOs, health systems, pathway vendors, etc.) aligned to GSK product and pipeline needs and work to inform, plan, develop and deliver key value evidence content enabling optimal engagement. Additionally, this role will assist the Field Heads and Operations Lead in field operational planning. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:<ul><li>Serve as the internal liaison between the Medical Accounts team and the Oncology therapeutic area and matrix partners including Value Evidence and Outcomes</li><li>Identify and/or anticipate PBDM needs in context of access and management, emerging data, new market entrants, etc.</li><li>Inform and represent the oncology needs of PBDM customers with internal partners including strategic and operational planning; evidence, content, and budget needs; medical voice of customer (mVOC), etc.</li><li>Lead the development of asset-related value evidence content/communication informed through field team, external customer feedback, ad boards, matrix partners, etc.</li><li>Support the development and communication of appropriate above brand educational initiatives aligned to therapeutic and brand strategies supporting optimal patient outcomes</li><li>Develop/deliver launch needs of new products, indications, data, etc. including engagement/listening priorities, training coordination and post-launch representation with internal teams.</li><li>Partner with Market Access team on value evidence needs and communication as well as customer engagement planning/coordination of new products, indications, data, etc.; to include coordination of any medical support for training.</li><li>Partner with FMAL asset leads and internal matrix teams to ensure PBDM medical content is relevant to needs of our customers.</li><li>Support pathway vender strategy and communication with internal partners.</li><li>Support appropriate digital outreach and/or educational programs at symposia Participate in process/change/capability initiatives for the Field Medical Accounts team.</li><li>Contribute to cultivating a strong, collaborative, and inclusive team culture within both the Medical Accounts team and the broader cross-functional GSK matrix teams.</li><li>Work closely with the Medical Accounts Field Heads to support the key field operational needs such as planning, team meetings, coverage map, access updates, etc.</li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li> Pharm D, PhD, M.P.H., M.S. required. </li><li> 5+ years' experience in any of the following or similar: US payer, health system; or similar managed care entity; US Medical Affairs / Pharma US Market Access / Pharma. </li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li>Excellent analytical, strategic thinking and communication skills. </li><li>Results-driven with strong problem-solving skills and a focus on developing customer centered strategies and content.</li><li>Strong communication and strategic skills; demonstrated ability to identify opportunities for medical engagement and develop strategic customer engagement and communication plans for PBDMs.</li><li>Ability to engage and develop/maintain strong relationships across the team and internal matrix partners as well as lead/info key decision. </li><li>Ability to perform in a fast-paced environment, manage multiple priorities simultaneously, work independently and effectively across functional teams</li><li>Direct experience in a payer, health system and/or managed care environment.</li></ul>#LI-GSK The annual base salary for new hires in this position ranges from $200,600 to $271,400 taking into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Director, Strategy & Value Communications - Oncology

Site Name: USA - Pennsylvania - Philadelphia Posted Date: Jul 17 2024 Are you energized by the challenge of accelerating a procurement organization at a biopharma company that cares about being ambitious for patients, while being accountable for impact and doing the right thing? If so, this Procurement Senior Manager role could be an exciting opportunity to consider. As a Procurement Senior Manager, you will be accountable for supporting the US business through the full procurement lifecycle from stakeholder engagement and sourcing to contracting and supplier management. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Strategy execution<ul><li>Represent the best interests of the market by aligning with appropriate Regional and Global category teams. Work in collaboration with these teams as the local expert to provide local business requirements and market information to support effective regional and global strategy creation and execution.</li><li>Execute global and local sourcing strategies for multiple spend categories in scope of responsibility, specifically Market Research/Data, Tech & Digital, and Media (Patient & Professional), operating with a truly global mindset and ensuring all applicable market or regional dimensions are accommodated.</li><li>Understand commercial standards and ensure category alignment for processes and services with third parties.</li><li>Support the business to understand GSK Procurement policies and ensure that users are trained / supported accordingly. Be the local expert on third party oversight and risk management frameworks to protect GSK in supplier interactions and contracting.</li></ul>Benefit delivery<ul><li>Ensure financial benefits are managed in accordance with the Global spend management framework. Ensure business unit and Finance agreement to financial value delivered and transparency on treatment of benefits in the budgeting process.</li><li>Deliver effective Procurement targets against budgets (Plans of Purchase) agreed with key stakeholders and Finance in accordance with the spend management framework and aligned to the global and regional budgets set out by the respective category teams.</li><li>Identify and deliver value to the business aligned to assurance of supply, quality, service, cost, and innovation and delivering stakeholders and business partner requirements through execution of category strategies.</li><li>Drive operational efficiencies by ensuring contract and preferred supplier list compliance as well as managing tail spend.</li></ul>Business partnering <ul><li>Build strategic relationships with local GSK stakeholders to understand business requirements, identify opportunities to create value, and to express Procurement's value proposition. Align sourcing strategies accordingly.</li><li>Influence key stakeholders and business partners to support strategy development, endorse recommended strategies, support execution, and agree how benefit delivery will be budgeted.</li><li>Ensure third party contracts are managed ahead of expiration dates for business continuity and strategic value.</li><li>Define and negotiate commercial terms and manage contracting process as required to meet business requirements in collaboration with legal support.</li></ul>External supplier relationships<ul><li>Execute and manage effective contracts with suppliers that will allow GSK to maximize opportunity globally and locally. Ensure global views on supplier negotiations are taken into consideration. Ensure all contracts are valid and updated in GSK's contract management system.</li><li>Manage the local supply base for the categories within scope through a robust supplier relationship and performance management process. Ensure supplier performance is understood and measured.</li><li>Ensure effective processes and communication links exist between the above country supplier organization structures and local and regional networks. Cascade these through supplier and GSK network and geographies.</li></ul>Supply chain and risk management<ul><li>Transform the supply chain to release value and make GSK more responsive to business and customer needs - for example in cost control, complexity reduction, simplification, best practice procurement and use of KPIs.</li><li>Identify and manage significant risks in the supply chain. Ensure appropriate mitigation plans are in place, in use, and that the risks are communicated appropriately within business units impacted.</li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>Bachelor's degree</li><li>5+ years of experience in Indirect procurement supporting, Marketing services, Market Research/Data, Tech & Digital, and Media/Media Agencies operations</li><li>Experience in procurement processes, third party contracting, stakeholder management, and supplier relationship management</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li>Pharma / Biotech experience in a highly regulated marketing environment requiring a high degree of understanding to ensure compliance. </li><li>Experience working with media Agencies and all media channels (traditional and digital), including support of media measurement, defining KPIs and optimizing campaign performance.</li><li>Effective communication skills to interact with stakeholders at various levels of the organization and our suppliers.</li><li>Comfortable working with ambiguity/limited information.</li><li>Negotiation and project management experience</li><li>Ability to work effectively and communicate with stakeholders across a large/matrixed organization.</li><li>Demonstrate expertise in Procurement processes, particularly with respect to developing and implementing significant strategies, stakeholder management and supplier relationship management.</li><li>Evaluate and solve issues, beware of risks, support implementation and robustly forecast spend and savings</li><li>Exceptional analytical skills.</li><li>Full knowledge to successfully utilize Microsoft tools and SAP Ariba modules. </li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Senior Manager, Procurement - US

Site Name: USA - Pennsylvania - King of Prussia Posted Date: Oct 4 2024 The Senior Scientist, Sterile Manufacturing Operations accountable for the sterile manufacture of clinical and pre-clinical sterile drug product, including planning, co-ordination, and manufacturing operations. Ensures all activities are conducted in full compliance with cGMP's, safety regulations, and critical business requirements. Develop into Technical subject matter expert for clinical operation activities as they relate to the UM Sterile Pilot Plant. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:<ul><li>Independently coordinate the daily activities of the area supporting the manufacture of early phase injectable products to support pre-clinical and clinical needs.</li><li>Ensure products manufactured are of the highest attainable level of quality and right first time.</li><li>Engage with Product Teams to resolve product development issues related to aseptic processing technology or sterile manufacturing equipment.</li><li>Ensure all production activities are performed following applicable cGMP's and GSK procedures</li><li>Ensure compliance with cGMPs, SOPs, and GSK standards of documentation to support sterile manufacturing.</li><li>Ensure that the manufacturing process remains compliant with all applicable regulations.</li><li>Provide expertise in the sterile manufacturing environment. Oversee the preparation of GMP/GLP documents such as Standard Operating Procedures, Production Forms, Logbooks, and Laboratory Notebooks.</li><li>Write, review, and approve SOP's and other technical documents for process equipment, facilities, and manufacturing processes</li><li>Assist in the technology transfer of processes to GSC and CMO sites; provide technical support for the development and introduction of novel manufacturing technologies.</li><li>May support third party manufacturing activities as a person in plant"</li></ul>Why you? Basic Qualifications : We are looking for professionals with these required skills to achieve our goals:<ul><li>Bachelor's Degree in Microbiology / Biology/ Engineering or similar science field</li><li>1+ year experience working with cGMP's and documentation principles for the manufacture of drug product in a highly regulated environment.</li><li>Experience working with aseptic techniques and sterility assurance in aseptic processing</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li>2+ years' experience working in a GMP drug product manufacturing environment is desired.</li><li>Ability to work in a complex, multi-tasking environment across local and functional boundaries</li><li>Knowledge of pharmaceutical pilot plant technical operations</li><li>Excellent oral and written communication skills</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Senior Scientist, Sterile Manufacturing Operations

Site Name: USA - Pennsylvania - King of Prussia Posted Date: Aug 22 2024 Are you looking for an opportunity to analyze and develop solutions to engineering problems related to manufacturing equipment and systems to determine causes of component failures? If so, this is the role for you. As a Sr MES Engineer professional you will Provide senior level technical support of manufacturing execution systems (Syncade) in a biopharmaceutical manufacturing facility. Provide technical backstop support of daily operations and drive continuous improvement and scaling of the existing footprint through the innovative and dynamic Smart Manufacturing 2030 Initiative This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:<ul><li>Provide support and technical subject matter expertise to the site's deployments of Emerson Syncade (manufacturing execution system). Ensure the reliable performance and continuous improvement/optimization the MES footprint. <ul><li>Recipe authoring, Equipment, Material, Order Management, software development and testing.</li><li>Troubleshoot plant floor MES execution and integration issues.</li><li>Change Control, Validation, and Qualification Management of system changes.</li><li>Compliance and inspection readiness of MES.</li></ul></li><li>Participate in and own responsibilities for further scaling of MES and other digital manufacturing system solutionse as part of the Smart Manufacturing 2030 Initiative by providing key input and ownership of solution design as well as project/executional design. This initiative is a collaborative multi-year, globally coordinated, and high visibility effort to digitize and streamline manufacturing processes with innovative technologies and strategies. </li><li>Lead/contribute to related capital investments. Rationalize performance and investment with business impact. </li><li>Maintain and upkeep Syncade through administration and break/fix support of related systems, networks, integrations, databases, and accounts. <ul><li>Able to query and assess the Syncade databases (SQL).</li><li>Perform hotfix upgrades in Syncade. Includes assessing change impact, provisioning in kind, performing the upgrade, testing, and hypercare. </li><li>Understand SC Consumer, Business Integrator, Event Monitor, OPC Client/Server, Infobatch Report Design and Integration, and troubleshoot performance and function of each component as it relates to the complete MES solution design (including other integrated systems and operational context).</li></ul></li><li>Understand the flow of data among business and operational technology systems, with a focus on Syncade, including technical nuances as well as operational context to make sense of the end to end flow.</li><li>Improve Department performance and posture through continuous improvement (e.g. procedural, way of working, capability, etc).</li><li>Collaborate with Operations and building stakeholders throughout the software or system development lifecycle: gather system/end user requirements; complete design, implementation, and testing/validation of changes; document changes; maintain and monitor the system; ensure end user readiness.</li><li>Work in a way that models respect for safety and EHS, quality compliance, data integrity, and engineering standards.</li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>Bachelor's degree</li><li>6+ years engineering, troubleshooting, and solutions design of Emerson Syncade, Körber/Werum PAS-X, Siemens Opcenter Execution Pharma (Simatic EBR), POMS, Rockwell PharmaSuite, or other Life Sciences focused MES systems.</li><li>4+ years working in a GMP manufacturing setting</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li>Strong quality/compliance orientation and track record. </li><li>Excellent interpersonal and leadership skills. </li><li>Strong influence and relationship building skills with an emphasis on teamwork</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Senior MES Engineer (Syncade)

Site Name: Upper Merion Posted Date: Jul 11 2024 As the Smart Manufacturing Project Manager, you will provide project management leadership to a matrix project team in pursuit of a digital transformation under GSK's Smart Manufacturing initiative. Provide organization and structure to the Upper Merion's project execution team to ensure efficient project operations, improve team productivity and effectiveness, and deliver project outcomes. Ultimately, this role must safely and compliantly ensure performance of the project against scope, cost, schedule, and benefit. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: <ul><li>Organize the site around design and delivery of Smart Manufacturing scope components focused on manufacturing data and execution. Provide matrix leadership, drive performance of the team and deliver project outcomes. <ul><li>Put into place a project management infrastructure (meetings, ways of working, tools, resources, etc.)</li><li>Develop and own the integrated project plan and resourcing plan. Manage project resources to execute the plan in a controlled manner. </li><li>Project controls - facilitate and monitor project spending, control cost and deliver performance as it relates to project cost - spend curve, overall costs, value for money, etc. Find project value through control of spending and project efficiencies. </li><li>Manage project risks and issues through PM structure, communication, and relationships.</li><li>Ensure project benefits and outcomes are delivered. Control scope and project evolution to ensure expected project benefits are delivered. </li><li>Use tools to digitize and organize the work (e.g. Microsoft suite of tools). </li></ul></li><li>Collaborate and coordinate with a variety of stakeholders in Upper Merion and across the enterprise to align the project throughout its life, with a focus on schedule, resources, scope, and business benefit. </li><li>Act as a key conduit for Smart Manufacturing to enable an effective program infrastructure. <ul><li>Work with the enterprise to ensure the holistic program is effective. For example, partner with central Project Controls to deliver integrated, holistic project controls for the program. </li><li>Manage site stakeholders to ensure Smart Manufacturing is aligned with other site objectives (e.g. competing resources, communications, and spend etc.).</li><li>Support the overall site program and site change management activities.</li></ul></li><li>Work through ambiguity & change. Navigate and manage a complex stakeholder map.<ul><li>Create clarity in areas of uncertainty and make progress at pace. </li><li>Drive toward decisions and consensus, even with partial data.</li><li>Manage site & enterprise dynamics (e.g. competing objectives, resource availability, scope/target evolution, etc.)</li></ul></li><li>Meet policy requirements and inject PM best practices into the way of working. Ensure safety, quality, and compliance are a project priority and reflected in the ways of working, role-modeled through team behaviors, and demonstrated during project execution & asset delivery. </li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>Bachelor of Science or Bachelor of Arts in Biological, Chemical Science, Engineering, or Digital technologies</li><li>5+ years of experience in a Life Sciences GMP setting</li><li>5+ years of project management experience</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li>Project management certification (e.g. PMP) is strongly preferred</li><li>Project management of complex, multi-year project(s) related to delivery of business technology (e.g. digital applications & technologies, execution systems, automation & robotics, etc.)</li><li>Experience partnering and managing technology vendors as it pertains to project design and delivery.</li><li>Direct engineering experience in MES (manufacturing execution system).</li><li>Direct engineering related to digital transformation (software development, process automation, robotics, etc.)</li><li>Direct biopharma (or life sciences) manufacturing experience.</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Smart Manufacturing Project Manager

Site Name: USA - Pennsylvania - King of Prussia Posted Date: Aug 29 2024 GSK is currently looking for a Sr. Digital and Data Science MSAT Manager to join our team in Upper Merion, PA. The Manufacturing Science and Technology (MSAT) organization is a site-based technical team responsible for ensuring manufacturing processes are capable, compliant and productive while maintaining product quality. The site MSAT team is also responsible for delivering continuous improvements to the existing supply chains supported by UM Biopharm and working with global MSAT to execute technology transfers and implement process-related improvement programs across the product lifecycle. The Senior Manager MSAT, Digital Systems and Processes serve as the site MSAT leader in the data and analytics space, supporting site initiatives and implementation of smart manufacturing principles in collaboration with the site digital and analytics teams and driving innovative solutions to complex technical problems. The Senior Manager will lead a team of data scientists and engineers to facilitate delivery of product and process data solutions in biologics manufacturing environment. This team will leverage data as a key asset to accelerate technology transfer and simplify validation processes, support continuous improvement for established commercial processes, and enhance technical understanding of biopharmaceutical manufacturing. The Senior Manager will be expected to support technical development of the MSAT organization, promoting technical and leadership capability to develop a high performing MSAT team and improving the data literacy and capability of the MSAT organization. The Senior Manager is also expected to manage within a matrix team to ensure alignment of data analytics platforms and approaches, collaborating with team members from other UM Biopharm departments (i.e. production, quality, engineering) and with stakeholders in central MSAT, data, and analytics teams to drive implementation of novel data analytics tools and technologies into the commercial manufacturing space. Key Responsibilities:<ul><li>Serve as the technical enterprise leader for data science and analytics capabilities for the MSAT team at UM Biopharm to deliver acceleration and simplification of new product introduction and robust commercial manufacturing for GSK supply chain and patients.</li><li>Accountable for the development and deployment of the strategic data and analytics plan for the UM MSAT Team, in collaboration with other site and central digital and analytics teams.</li><li>Drive innovation through leading continuous improvement for technical processes or systems and championing introduction of novel technologies, including new modeling platforms and approaches (first-principle modeling, CFD, machine learning), digital systems and visualizations, and process analytical technologies (PAT).</li><li>Lead a team of scientists and engineers to work collaboratively and efficiently to deliver the technical objectives. Support capability development of the MSAT team to learn/implement new analytical technologies and modeling systems.</li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li>BS/BA degree in a science related field (i.e, biological, chemical, data/computer science, engineering) with 5+ years of digital, data, and analytics experience in the healthcare, pharmaceutical, laboratory, or manufacturing industry.</li></ul>OR<ul><li>MS or PhD degree in a science related field (i.e, biological, chemical, data/computer science, engineering) with 3+ years digital, data, and analytics experience in the healthcare, pharmaceutical, laboratory, or manufacturing industry.</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li>MS or Ph.D. in data/computer science or engineering, biological or chemical science or engineering or equivalent technical discipline. </li><li>In-depth experience with digital, data, and analytics techniques in the pharmaceutical industry. Specific experience or knowledge of biopharmaceutical manufacturing (upstream / downstream) is preferred.</li><li>Experience with industrialization or implementation of models in a GMP environment, including development of model lifecycle management framework and integration into regulatory filings is preferred</li><li>Familiarity and experience with relational databases, statistical softwares (i.e. SAS, SIMCA), modeling and visualization softwares (i.e. Python, R, Matlab, MS Power). Experience of developing or applying techniques such as pre-processing, classification, regression, clustering, dimensionality reduction and model selection.</li><li>Experience with manufacturing / engineering environments including systems such as IP-21, M-ERP, LIMS, Aspen eBRs.</li><li>Knowledge of GMPs and major regulatory agency regulations, specifically as they relate to data science or data validation.</li><li>Strong interpersonal and leadership skills to manage a technical team and cross-functional teams. Prior experience managing a team or matrix team preferred.</li><li>Strong verbal and written communication skills particularly in the area of technical and regulatory related matters. Able to present data science / statistical methods to non-statistical team members.</li><li>Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines. Embraces a team-based culture.</li><li>Demonstrates initiative to solve problems, effective at making and implementing decisions.</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Senior Manager, MSAT Digital and Data Science

Site Name: USA - Pennsylvania - King of Prussia Posted Date: Jul 18 2024 As an Investigator, within Sterile Operations, you will be responsible for the site-based hands-on manufacturing of sterile clinical drug product. You will also be accountable for batch preparation activities; including planning, forecasting and coordinating manufacture to meet agreed project timelines. You will be responsible for assisting in the development efforts required bringing the clinical supplies (product) into the UM pilot plant and technical transfer to GSK commercial sites. You will also support due-diligence efforts and/or provide person-in-plant support at external contractor sites. Key Responsibilities:<ul><li>Perform hands-on manufacturing of parenteral products, through leading batch activities in the pilot plant and pre-clinical manufacturing areas.</li><li>Coordinate with project teams to understand the drug product manufacturing process and provide technical expertise to introduce the process into to the Sterile Manufacturing pilot plant in a compliant manner.</li><li>Interface with manufacturing operations to ensure day to day activities are scheduled and managed appropriately.</li><li>Strong understanding and application of aseptic manufacturing principles to implement new technologies / process to the Sterile pilot plant.</li><li>Ensure compliance with cGMPs, SOPs, and GSK standards of documentation to support sterile manufacturing.</li><li>Ensure that manufacturing processes remain compliant with all regulatory expectations and GSK policies and standards.</li><li>Provide technical expertise in the sterile manufacturing environment, participate in audits of external manufacturing sites as needed.</li><li>Oversee the preparation of GMP/GLP documents such as Standard Operating Procedures, Production Forms, batch records, Logbooks, and Laboratory Notebooks.</li><li>Prepare and review master batch records, process documentation, and bulk production records as needed.</li><li>Inspect work area for safety regulations and recommend improvements.</li><li>Support external due diligence efforts and technical support for manufacturing at CMO sites as needed.</li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>Master's or Bachelor's Degree in a scientific discipline with (2-3) years experience supporting sterile manufacturing / sterile formulation development</li><li>Experience working / transferring processes to a cGMP environment (2-5 years)</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li>PhD in Chemistry, Microbiology, or Pharmaceutical Sciences or related field with 0-3 years experience in the manufacture / formulation development of sterile drug products</li><li>Thorough knowledge of, and experience working with long acting injectables</li><li>Experience in formulation / manufacture of lyophilized dosage forms. </li><li>Grade B gown qualification or willingness to seek qualification as part of role expectations. </li><li>Awareness of aseptic principles and sterility assurance in aseptic processing</li><li>Ability to work in a complex, multi-tasking environment across local and functional boundaries.</li><li>Ability to organize and effectively lead multiple diverse, cross-functional teams </li><li>Excellent oral and written communication skills; commitment to transparency; ability to build consensus and effectively negotiate resolution to complex technical and business issues</li><li>Thorough knowledge of, and experience working with, cGMP's and documentation principles for the manufacture of sterile drug products, or similar highly regulated environment</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Investigator, Sterile Operations

Site Name: USA - Massachusetts - Waltham, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence Posted Date: Jul 17 2024 The Associate Director of Analytical Development will lead a team of analytical scientists responsible for development, manufacturing, release and stability testing, and characterization of drug substances/API and drug products of Small Molecule and Oligonucleotide therapeutic modalities within the Strategic External Development (SED) organization. The Associate Director will be responsible for people and project management, who would also function as an analytical project lead and technical lead in a broad analytical development role that spans from managing collaboration with appointed CDMOs to overseeing, developing, and executing aligned GSK and CDMO goals for development of small molecules and oligonucleotides. It will further extend to investigation, preparation and reviewing of CMC content for regulatory submissions, as well as response to regulatory agencies. This role will provide YOU the opportunity to lead team and key activities to progress YOUR career, these responsibilities include some of the following... <ul><li>Provide leadership, guidance, and strategic direction to a group of analytical scientists and ensure staff are developed to their fullest potentials by providing coaching, mentoring, and appropriate learning opportunities.</li><li>Provide leadership to the team in development of scientific capability and analytical strategies, with accountability for oversight of analytical activities performed at external partners.</li><li>Provide clear communication to team and partners as well as functional line and matrix management regarding progress against technical / project as well as organizational objectives/milestones. </li><li> Build and maintain strong relationships with internal and external partners to ensure successful analytical strategies are positioned and implemented for the pipelines within the organization. </li><li>Develop and execute strategies and process characterization with a focus on product quality assessment, specification, release, stability and comparability studies.</li><li>Collaborate with process, formulation and quality functions to ensure strong cross functional collaborations and integrated process and product development and characterization.</li><li>Author, review and/or approve key source documents for relevant sections of regulatory filings examples could be IND, IMPD, NDA, or MAA.</li><li>Lead and track analytical development commitments of project and team's deliveries to support all CMC filing activities such as pre-INDs, INDs, IMPDs, CTAs or NDAs, and review of regulatory filings, and address RTQs.</li></ul><ul><li>Assure all documentations and other regulatory compliance systems are maintained according to GSK corporate standards.</li><li>Establish and implement processes, technical concept and methodologies to enable effective collaboration with CRO/CDMO business partners to ensure efficiency and high quality of results.</li><li>Partner with Quality Assurance and Regulatory Affairs-CMC to ensure completion of appropriate documentation and maintenance of high-quality standards.</li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: For the Small Molecule and Oligonucleotide modality roles: <ul><li>M.S. or Ph.D. degree in analytical chemistry, chemistry, or chemical engineering with pharmaceutical industry experience </li><li>10 or more years analytical development experience</li><li>3 or more years of experience in late-stage product and process development and market application of small molecule or oligonucleotide therapeutics.</li><li>3 or more years of people management and analytical project leadership experience.</li><li>5 or years of experience in analytical assay development, qualification and validation .</li><li>2 or more years of experience in methods tech transfer of and life cycle management.</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li>Exposure to all stages of drug development.</li><li>Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts.</li><li>Experience with mRNA, peptides and conjugated biologic therapeutics modalities.</li><li>Ability to work in a fast-paced, multi-disciplinary and dynamic environment with potential for changing priorities, with flexibility to support multiple development programs simultaneously.</li><li>Ability to lead innovation and drive for results.</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Associate Director (Team Lead), Analytical Development, SED-4

Site Name: USA - Pennsylvania - Upper Providence Posted Date: Sep 11 2024 The US EHS R&D Environmental Manager will serve as a full member of the EHS R&D team which includes providing EHS support to R&D, support to capital and site minor works projects and emergency response to the site, conduct incident investigations, etc. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:<ul><li>To serve as a full member of the EHS R&D team which includes providing EHS support to R&D, support to capital and site minor works projects and emergency response to the site, conduct incident investigations, etc.</li><li>Partner with the R&D business on compliance with on GSK and federal/state regulations and standards</li><li>To ensure the interests of the business are represented and protected, both within and external to GSK. To maintain comprehensive external and cross business awareness and lead and participate in significant cross company initiatives.</li><li>Manage the environmental compliance program or the R&D sites including air, wastewater, stormwater, registered storage tanks, RCRA and regulated waste, SPCC, SARA Tier II, TRI, Act 2 remediation etc.:<ul><li>Maintain environmental permits as required for site operations. Responsible for submittal of applications for new permits and renewals</li><li>Manage all environmental regulatory report submissions to federal, state, and local authorities</li><li>Maintain response plans as required by regulatory requirements including PPC, SPCC, and RCRA contingency</li><li>Act as subject matter expert for the handling and containerizing of hazardous waste in the R&D laboratories</li><li>Serve as primary point of contact for all environmental interactions with the DEP, EPA and local authorities</li></ul></li></ul>Manage the review of wastewater disposal requests by R&D<ul><li>Accountable for alerting management to legislative development in the areas of Environmental regulations</li><li>Accountable for full compliance on environmental regulatory submissions</li><li>Represent the interests of GSK in key external policy forums</li><li>Champion the interests of stakeholders within the business in GSK EHS policy and strategy development</li></ul>Why you? Basic Qualifications: <ul><li>Bachelor's Degree in Environmental Engineering, Environmental Sciences or other Environmental or Science related degree.</li><li>5+ years of Environmental Management experience to include experience in environmental regulatory reporting for Title V, wastewater, etc.</li><li>Experience working with legislation relating to industrial hygiene, safety & environment</li></ul> Preferred Qualifications: <ul><li>An awareness of current developments and emerging scientific & technical issues.</li><li>Strong leadership abilities to influence senior GSK managers and staff in a demanding and rapidly evolving legislative environment.</li><li> Good interpersonal, presentational, and persuasive skills so as to successfully interact with managers at all levels and the ability to manage complex internal relations on a multi-site and international basis.</li><li>Good knowledge of the business and a good net worker.</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.