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. You will lead the development, industrialisation, and lifecycle delivery of the assigned physical medicine (either small molecule, biopharm or CGT) 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 & CMC/SC lifecycle work.

The role holder:

• engages with the medicine 6 to 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;
• ensures the successful execution of the process performance qualification (PPQ), establishing continuous process verification (CPV) and pre-approval inspection readiness;
• ensures the global file, review, and launch readiness;
• delivers the further lifecycle P3 studies and CMC/SC sub-projects;
• transitions to the MSCL and the further lifecycle, and supports the completion of any lifecycle projects specified by the lifecycle plan.

The Sr. Director role leads projects with CMC budgets in the >£30M range and/or peak year sales in excess of £500M. The role is complemented with a director role which leads projects with CMC budgets in the < £30M range and/or peak year sales < £500M.

Key Responsibilities:

• Accountable for the seamless transition and knowledge transfer from the pre-C2P2 period and eMDCL, through to P2 and P3/commercial process development.
• The role holder will engage with early CMC Medicine Development CMC Leader and team ~6 to 12 months prior to C2P2 to prepare plans, resources (external and internal spends budgets for the C2P2 recommendations).
• Helps define the medicine development strategy and the medicine commercial vision through the Medicine Development Leader (MDL) and Medicine Development Team (MDT); define the drug substance (DS), drug product (DP) device, analytical, manufacturing, supply chain, quality, and CMC regulatory approaches through the CMC/SC matrix team.
• Generate options and recommendations for P3 development & supply, and global regulatory filings that balance time, costs, resources, and risk.
• Ensure requirements 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/SC matrix team, including DS, DP, device, analytical, manufacturing, supply chain, Quality Assurance (QA), regulatory, data, statistics, and project management.
• 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.
• 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 ToA contract with the MSCL.
• 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.
• Provide the voice of the physical product to the MDL/MDT & Development, and through the MSCL to the MCL/MCT & Commercial.
• After completing the transfer of accountability (ToA) contract commitments, seamlessly transfer knowledge and plans to the Medicine Supply Chain Leader (MSCL).
• May additionally: line manage MDI Directors; lead collaboration interfaces; lead CMC/SC due diligence reviews; and/or lead systems and process updates.

Why You?

We are seeking professionals with the following required skills and qualifications:

• BSc or PhD in Life sciences, (bio)chemical engineering, pharmaceutical sciences or relevant area.
• Significant experience of pharmaceuticals, CMC & SC.
• Experience at the director or preferably senior director level.
• Experience of developing, presenting, and defending P2, P3 & lifecycle CMC/SC strategies, plans and resources to governance.
• Experience working with, and influencing, very senior leaders internally and externally.
• Leadership of international, multi-disciplinary P2, P3 & lifecycle CMC/SC teams.
• Experience developing people as a mentor, coach, teacher and either a matrix and/or line leader.
• Proven success leading cross-functional teams in a matrix environment.
• Breadth and depth of experience of P2, P3 & lifecycle CMC and supply chain aspects.
• Strong hands-on experience in CMC through late-stage development for small molecules, biologics or advanced modalities.
• Practical experience with tech transfer, process scale-up and external manufacturing.
• Experience authoring or contributing to CMC sections of regulatory submissions.
• Clear decision-making, problem solving and communication skills for technical and non-technical audiences.

Work Location:

This role can be based at Ware, United Kingdom OR Upper Providence, USA and offers a hybrid working model, combining on-site and remote work. Fully remote arrangements are not available.

Ready to take the next step?

If you are excited to lead CMC for impactful medicines and grow your career, please apply. Tell us how your experience will help get medicines to patients faster.

Closing Date: 16th July 2026

Why GSK?

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.

GSK is an Equal Opportunity Employer.