We develop, manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we develop and manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.
To lead the development, industrialisation, and lifecycle delivery of the assigned physical medicine (either small molecule or oligonucleotide) from Commit to Phase 2 (C2P2), through the development of the Phase 3 (P3)/commercial process, the file, review and launch and the completion of the major clinical and CMC/Supply Chain (SC) lifecycle work. The role holder: i) engages with the medicine 6 to 12 months prior to C2P2; ii) takes accountability from the early CMC Leader at C2P2; iii) leads delivery of the P3/commercial process, clinical supplies and files; iv) leads the project through the successful execution of the Product Performance Qualification (PPQ), establishing continuous process verification (CPV) and PAI readiness; v) supports the global file, review, and launch readiness; vi) supports or delivers the further lifecycle P3 studies and CMC/SC sub-projects; and then vii) transitions to the GSC Strategy Lead and the further lifecycle, and supports the completion of any lifecycle projects specified by the lifecycle plan.
Accountable for the seamless transition and knowledge transfer from the pre-C2P2 period, through to P2 and P3/commercial process development. The role holder will engage with early CMC Medicine Development CMC Leader and team ~6 to 12mths prior to C2P2 to prepare plans, resources (external and internal spends budgets for the C2P2 recommendations (noting that the timing may be earlier than C2P2 for complex, accelerated medicines)
Helps define the medicine development strategy and the medicine commercial vision through the Medicine Development Leader (MDL) and Medicine Development Team (MDT) MDL/MDT; define the drug substance (DS), drug product (DP) device, analytical, manufacturing, supply chain, quality, and CMC regulatory approaches through the CMC matrix team. Generate options and recommendations for P3 development & supply, and global regulatory filings that balance time, costs, resources, and risk. Ensure requirements these are captured in the medicine CMC/SC master strategy & plan and securing timely decisions on them through governance.
Deliver the strategy & plan through the CMC matrix team, including DS, DP, device, analytical, manufacturing, supply chain, Quality Assurance (QA), regulatory, data, statistics, and project management, and in turn through the R&D, GSC and external contract development and manufacturing network, to the agreed timings, resources, and risk mitigation strategies. Manage integration, alignment and performance proactively, anticipating and addressing issues and risks, and securing Specialist Sign Off (SSO) and Subject Matter Expert (SME) inputs, as necessary throughout product development
The role holder continually monitors for scope changes or threshold breaches in terms of the agreed timing, costs, resources and/or risks (and in relation to the agreed lifecycle sub-project strategy, plan & warranty contract considerations), and engages with senior leaders and/or governance as necessary, to resolve these proactively
During P3, generate options and recommendations for Product Performance Qualification (PPQ), PAI readiness, global commercial file and launch, and that balance time, resources (EPE & IPE), and risk. Ensure these are captured in the medicine CMC/SC master strategy & plan and develop the Transition of Accountability (ToA) contract with the GSC Strategy Lead. Secure timely decisions on milestone progression through governance.
During P3 and prior to file/launch, identify post-launch medicine development and commercial needs through the MDL/MDT and the MSCL and the MCL/MCT. Define the DS, DP, device, analytical, manufacturing, supply chain, quality, and CMC regulatory approaches for lifecycle plans. Generate options and recommendations that balance time, costs, resources and risk. Ensuring plans are captured in the further medicine CMC/SC master strategy & ToA contract (including all of the lifecycle P3 and CMC/SC sub-projects and responsibilities). Secure timely decisions on plans through governance.
Provide the voice of the physical product to the MDL/MDT & Development, and through the MSCL to the MCL/MCT & Commercial, and the corresponding voice of the project to the CMC/SC matrix team, the CMC modalities & GSC
After completing the transfer of accountability (ToA) contract commitments, seamlessly transfer knowledge and plans to the GSC Strategy Lead, and then, as applicable, lead any follow on development activities, including support for specific marketing files, further P3 trials and specific development targets (e.g., paediatric sub-projects), and represent these to the ongoing MDL/MDT and in support of the MSCL and Medicine Commercial Leader / Team (MCL/MCT)
Extensive experience of pharmaceuticals, CMC and Supply Chain
The role requires an understanding of CMC disciplines related to the delivery of a large, produced product.
Area of specialisation in Chemistry, Life Sciences or Bio/chemical engineering.
Project leadership experience, specifically leadership of multi-disciplinary matrix teams and preferably in a biopharmaceutical product development environment with global teams.
Broad and deep understanding of how medicines are developed and brought to market.
Demonstrated delivery of a product through the technology transfer process in some capacity.
Significant experience of late phase CMC/supply chain development and commercialisation.
Knowledge of global biopharmaceutical pharmaceutical CMC regulatory requirements.
Advanced degree, PhD, MBA, or equivalent experience in a relevant scientific, technical, or business discipline.
Broad experience across multiple medicine modalities, such as small molecules, oligonucleotides, biologics, or other advanced therapeutic platforms.
Experience supporting global product development, regulatory submissions, launch planning, or commercial supply readiness.
Track record of leading through complexity, managing uncertainty, and enabling high-quality decision-making across senior stakeholder groups.
Experience operating at the interface of R&D, Supply Chain, Technical, Quality, Regulatory, and Commercial teams.
Strong external awareness of CMC trends, regulatory expectations, and pharmaceutical development best practice.
This role can be based at Stevenage (UK), Ware (UK) or Upper Providence (USA) and offers a hybrid working model, combining on-site and remote work.
Closing Date for Applications: 10 July 2026
Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter, and CV will be used to assess your application.
#Li-Hybrid
How to apply
If this role motivates you, please apply. Share your CV and a short note explaining why the role excites you and how your experience fits our needs. We welcome applicants from different backgrounds and support inclusion in our teams.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [email protected] where you can also request a call.
Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide.
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 the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/
