GSK
Small Molecule CMC Leader - Senior Director
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Small Molecule CMC Leader - Senior Director
Senior Director, Chemistry Manufacturing and Controls (CMC) Project Leadership
Position Summary
You will lead CMC (Chemistry, Manufacturing and Controls) for a Medicines Development and Innovation programme. The role spans the full lifecycle of a physical medicine (e.g., small molecule, biopharmaceutical, or CGT), from Commit to Phase 2 (C2P2) through Phase 3 (P3)/commercial process development, regulatory filings, launch, and major lifecycle work—delivering projects with CMC budgets of >£30M or peak-year sales exceeding £500M.
The Senior Director is accountable for:
- Engaging 6–12 months prior to C2P2 to align teams and resources.
- Taking full ownership at C2P2 from the early CMC Leader.
- Leading P3/commercial process development, clinical supplies, and file readiness.
- Ensuring Process Performance Qualification (PPQ) success, continuous process verification (CPV), and pre-approval inspection readiness.
- Driving global filings, reviews, and commercial launch readiness.
- Delivering P3 studies, CMC/SC sub-projects, and seamlessly transitioning to the Medicine Supply Chain Leader (MSCL).
- Supporting post-launch lifecycle initiatives and resolving any warranty concerns.
Key Responsibilities
Strategic & Cross-Functional Leadership
- Facilitate a smooth transition from the early Medicine Delivery & Commercial Leadership (eMDCL) phase to P2 and P3.
- Collaborate with the Medicine Development Leader (MDL) and Medicine Development Team (MDT) to define:
- Drug substance (DS), drug product (DP), device, analytical, manufacturing, supply chain (SC), induration, and regulatory approaches.
- Develop cost-, risk-, and resource-balanced recommendations for:
- P3 development & supply.
- Global regulatory filings.
- Ensure these are integrated into the CMC/SC master strategy & plan and secured via governance (i.e., CMC Board, Development Review Board, Portfolio Investment Board).
Project & Programme Delivery
- Execute the CMC/SC strategy through a multi-disciplinary matrix team, including:
- DS/DP, analytical, manufacturing, supply chain, Quality Assurance (QA), regulatory, data/statistics, and project managers.
- Engage with R&D, GSC (Global Supply Chain), and external CDMOs to ensure timely delivery against scope, budget, and risk mitigation timelines.
- Proactively identify integration risks and seek Specialist Sign-Off (SSO) & Subject Matter Expert (SME) inputs.
- Swap throat changes (timelines, costs, scope/risks) to senior leadership and rechannel governance escalations.
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Regulatory & Compliance
- Lead PPQ readiness, pre-approval inspection (PAI) alignment, global file build-out, and commercial launch planning.
- Define P3 and lifecycle post-launch needs with the MDL/MDT, MSCL, and Medicine Commercial Leader (MCL/MT).
- Construct lifecycle CMC/SC strategies and secure approval across governance, linking to regulatory and manufacturing obligations.
Recovery & Team Transition
- Upon Transfer of Accountability (ToA), smoothly hand over knowledge and strategies to the MSCL.
- Retain follow-on responsibilities as needed (e.g., additional P3 trials, pediatric sub-projects, or marketing filings).
- Support ongoing strategic alignment with the MDL/MDT, MSCL, and MCL/MT.
Collaborative Leadership (As Applicable)
- Line manage MDI Directors.
- Oversee collaboration interfaces with external parties and CMC/SC diligence reviews.
- Drive systems and process updates for continuous improvement.
Why You?
Essential Requirements
- Degree in Life Sciences, (Bio)chemical Engineering, Pharmaceutical Sciences, or relevant field (BSc/MSc)** or PhD.
- 10+ years of pharmaceutical CMC/SC experience, with director or senior director-level leadership.
- Hands-on expertise in:
- P2, P3, and lifecycle CMC/SC strategy, plans, and resource management.
- Engaging with global health authorities (US, EU, Japan, China) across drug submissions and pre-approval inspections.
- Strong track record of leading:
- International, multi-disciplinary teams (external CDMOs, cross-functional R&D).
- End-to-end project deliveries from process scale-up to commercial launch.
- Decentralized tech transfer, regulatory compliance, and quality compliance (ICH, GMP).
- Proven mentorship & coach leadership, managing cross-functional matrix or line teams.
- Decision-making, problem-solving, and stakeholder communication across technical and commercial audiences.
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Preferred Skills
- Regulatory expertise in Cultural (Chinese) or Japanese/GMP environments.
- Experience in advanced modalities (Gene/Cell Therapy) or adaptor/multimodal therapies.
- Extensive exposure to clinical manufacturers and clinical supply support.
Working Environment
- Flexible hybrid model with remote flexibility (excluding fully remote roles).
- Locations:
- Ware (UK)
- Upper Providence (USA)
Why GSK?
GSK is a global biopharmaceutical company uniting science, technology, and talent to impact the health of 2.5 billion people by the end of the decade. Our mission:
- Prevent and treat disease via specialized vaccines and immunotherapies.
- Focus on 4 key therapeutic areas:
- Respiratory (including immunology/inflammation).
- Oncology.
- HIV.
- Infectious diseases.
We foster a culture of:
- Patient-first ambition.
- Accountability in purpose.
- Ethical integrity.
Equal Opportunity Employer: We welcome applications irrespective of race, gender identity, age, disability, or veteran status.
Hybrid working is available; adjust to roles aligned with your needs. Flexibility requests may be channeled through:
Details on EEO commitments:
For further guidance, review GSK’s equity initiatives at our Career Site.
Take the Next Step
Apply now to lead an inspiring CMC initiative and grow your career. Your vision accelerates patient impact.
Closing Date: 16th July 2026
- We recommend applying ahead of schedule for attentive consideration.
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