CMC Leader (Director)

Business Introduction 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 is 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. Position Summary 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 engages with the medicine 6‑12 months prior to C2P2, takes accountability from the early CMC Leader at C2P2, leads delivery of the P3/commercial process, clinical supplies and files, leads the project through the successful execution of the Product Performance Qualification (PPQ), establishes continuous process verification (CPV) and PAI readiness, supports the global file, review and launch readiness, delivers the further lifecycle P3 studies and CMC/SC sub‑projects, and then transitions to the GSC Strategy Lead to support the completion of any lifecycle projects specified by the lifecycle plan. Responsibilities Accountable for the seamless transition and knowledge transfer from the pre‑C2P2 period through to P2 and P3/commercial process development, engaging with the early CMC Medicine Development CMC Leader and team 6‑12 months prior to C2P2 to prepare plans, resources and budgets. Helps define the medicine development strategy and the medicine commercial vision through the MDL/MDT, and defines the drug substance, drug product, device, analytical, manufacturing, supply chain, quality, and CMC regulatory approaches through the CMC matrix team, generating options and recommendations for P3 development & supply. Delivers the strategy & plan through the CMC matrix team, ensuring integration, alignment and performance proactively, anticipating and addressing issues and risks, securing Specialist Sign Off and Subject Matter Expert inputs throughout product development. Monitors scope changes or threshold breaches in timing, costs, resources or risks, engaging with senior leaders and governance to resolve proactively. During P3, generates options and recommendations for PPQ, PAI readiness, global commercial file and launch, and ensures capture in the medicine CMC/SC master strategy and plan, developing the Transition of Accountability contract with the GSC Strategy Lead. During P3 and prior to file/launch, identifies post‑launch medicine development and commercial needs, defines approaches for lifecycle plans, generates options and recommendations, and ensures plans are captured in the further medicine CMC/SC master strategy & ToA contract. Provides 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 contract commitments, seamlessly transfers knowledge and plans to the GSC Strategy Lead, and then leads any follow‑on development activities, including support for specific marketing files, further P3 trials and specific development targets (e.g., paediatric sub‑projects). Basic Qualifications Extensive experience of pharmaceuticals, CMC and Supply Chain. 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 CMC regulatory requirements. Preferred Qualifications 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. Work Location 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 Equal Opportunity Employer GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, colour, 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. #J-18808-Ljbffr GlaxoSmithKline