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CMC Leader (Director)
Global Project Lead, Physical Product and Supply Chain (C2P2 to Commercial)
About the Role
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 improve the health of millions.
The Supply Chain is central to our operations, enabling us to bring our innovations to patients quickly, efficiently, and effectively. Technology is transforming how we innovate and produce medicines and vaccines, empowering us to create safer, faster, and more scalable treatments.
This critical role will guide the design, industrialisation, and lifecycle delivery of assigned physical medicine (either small molecule or oligonucleotide), covering the entire journey from Commit to Phase 2 (C2P2) through Phase 3 (P3), regulatory filings, product launch, and major clinical & CMC/Supply Chain (SC) lifecycle work.
Key Responsibilities:
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Engage early with the medicine team 6–12 months prior to C2P2:
- Engage with CMC Medicine Development’s CMC Leader and team to align on plans and resource requirements (internal/external spends).
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Lead the C2P2 -> P3&Commercial transition:
- Work closely with Sponsor/Project Managers to integrate technical risk planning into the strategic development.
- Support decisions at C2P2 Milestone Gate and steward development through P3, commercialisation, and beyond.
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Drive Phase 3, Commercial, & Regulatory Strategies:
- Ensure Product Performance Qualification (PPQ), Continuous Process Verification (CPV), and Product & Process Analytics Intelligence (PAI) showcase high-performing processes.
- Execute for necessary global regulatory filings, drug approval process, launch readiness, and supply chain alignment, ensuring commercialisation success.
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Author CMC/Supply Chain strategy and track peak lifecycle investments:
- Generate an end-to-end CMC & Supply Chain (SC) strategy and master plan, addressing both production processes and clinical trial supply needs.
- Monitor dates, cost, resource, and risk balances as part of a structured lifecycle investment plan (Priority Sizes, PharmaRep, IPA/Risk Workshop).
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Technical & Stakeholder Leadership:
- As Voice of the Physical Product, work within the MDL/MDT & CMC Matrix — including DS, DP, Device, Analytical, Manufacturing, Supply Chain, Quality & Regulatory teams — to propose risk/opportunity-based strategies.
- Represent the global project (multidisciplinary teams across R&D, Global Supply Chain (GSC), and external CDMOs) with a strong analysis of critical legal and technical risks.
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Deliver CMC, SC & Regulatory Excellence Globally:
- Own all COGs for Physical Product Development and deliver SPE to achieve contract milestones.
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Monitor & Grow throughout Product Lifecycle:
- Transition accountability to the GSC Strategy Lead while providing guidance on lifecycle P3 studies and future development goals (e.g., paediatric ПаундӀдей, toxicity studies).
Responsibilities
- Seamless Transition Management: Oversee the shift from pre-C2P2, through P2 development, to P3 and commercialisation. Collaborate 6–12 months prior to C2P2 with CMC Medicine Development’s leadership to prepare aligned plans (prioritising secure, safe, and efficient external suppliers and internal expenditure allocation).
- Peak Strategy & Governance:
- Investment micro-review with the MDL/MSCL & Manufacturing Business Units via the GSC Strategy Lead.
- Enable trade-off decision-making via technical risks and business needs, ensuring robust strategies informed by leadership inputs.
- Project & Safety Validation:
- Lead PPQ, PAI, and global commercial/launch preparations, ensuring regulatory-level processes, quality checks, and timely deployment.
- Current vs. Future Solutions: Monitor for scope changes that might affect timelines, costs, risk, or other lifecycle project initial timelines or strategic considerations.
- Launch & Lifecycle Stewardship:
- Engage medicine leaders & development teams to identify post-launch needs, including supporting emerging requirements (marketing, deficiency filing patches, taxes, FFT suppliers, and PAI adroit numbers).
- Implement appropriate P3, SC strategies, prioritising costs, resource distribution, and alignment with project goals. Work closely with the GSC Lifecycle Supplements team.
Key Focus Areas
- Physical Product & Supply Chain Growth:
- Coach R&D/commercial functions on process strength and predictability for future expansion (fill/finish capacity, macromolecule supply chains, etc.).
- Technical Mastery & Coordination:
- Lead interfacing needs with "CMC Modality Leads" and ensure smooth operation between multidisciplinary R&D/Science Supply Chains.
- Prime Fresh Transition:
- Ensure successful end-to-end product delivery post-PQC through sustaining that number clarity trips projections, integrated timely changes are embedded in source tracking.
- Own Correlation and integration studies between QbD product/process and in vitro processes, ensuring their transfer is both risk-assessed and compliant.
Qualifications & Skills


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Required Experience & Expertise:
- Industry Expertise: Extensive pharmaceutical, CMC, and Supply Chain knowledge specialising in physical medicine development for multimodalities or small molecules/oligonucleotides.
- Technical Background: A degree in Chemistry, Life Sciences, or Biochemical Engineering.
- Project Management: Proven ability to lead complex, matrixed teams in biopharmaceutical C2P2 stages, ensuring commercial production readiness, supply continuity, and P3 submissions.
- Regulatory Compliance & Standards: In-depth knowledge of global pharmaceutical regulatory frameworks.
Preferred Expertise:
- A postgraduate degree (PhD, MBA, etc.) or relevant doctoral programme.
- Industry experience spanning a diversity of modalities (small molecules, biologics, other emerging technologies).
- Familiarity with global approval processes, launch plans, and commercial requirement reporting.
- Capability to thrive in high-uncertainty environments, uniting R&D, QA, Tech, Regulatory, Commercial, and Supply Chain for strategic success.
- Vigilance on emerging medical trends, procedures, and development best practices.
- Exposure to physics-based testing, supplier underwriting/sourcing, and fund governance.
Why GSK?
At GSK, we unite science, technology, and talent to stay ahead of diseases – from prevention & treatment to preventing epidemics. Our ambitions are aligned with global health goals:
- Four key focus areas: respiratory, immunology/inflammation; oncology; HIV; and infectious diseases.
- Purpose-driven: We aim to impact the health of 2.5 billion people by the next decade.
- Work culture: Purpose-aligned, accountable, ethical.
We support inclusivity and empower our teams to thrive while making a real difference.
Join us – where innovation meets real-world impact.
Work Arrangement
This position is hybrid (Stevenage (UK), Ware (UK) or Upper Providence (PA, USA)), with negotiations on your preferred location and working schedule.
Application Closing Date:
10 July 2026
GSK is an Equal Opportunity Employer. Applications will be reviewed based on merit and professional qualifications. We recognise and value the richness of individual differences and promote diversity and inclusion. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or any attribute protected by relevant local, state, or federal law (where applicable). pandemia recognition amended by pregnancy considerations.
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