Small Molecule CMC Leader Senior Director

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: i) engages with the medicine 6 to 12mths 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) ensures the successful execution of the process performance qualification (PPQ) establishing continuous process verification (CPV) and pre-approval inspection readiness; v) ensures the global file review and launch readiness; vi) delivers the further lifecycle P3 studies and CMC/SC sub-projects; and then vii) 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.

• 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 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/SC 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 (CMC board Development Review Board & Portfolio Investment Board)

• 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 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 (CMC board DRB and/or PIB) 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 ToA contract with the MSCL. Secure timely decisions on milestone progression through governance (CMC board DRB & PIB)

• 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 (CMC board DRB & PIB).

• 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 Medicine Supply Chain Leader (MSCL) 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)

• May additionally: line manage MDI Directors; lead collaboration interfaces; lead CMC/SC due diligence reviews; and/or lead systems and process updates

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• 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 for ca.

• 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 through decision making changes issues and risk management: this should include US EU Japan & China health authorities and in both the marketing review and pre-approval inspection settings

• Leadership of international multi-disciplinary P2 P3 & lifecycle CMC/SC teams; this should include external collaborators and CDMOs; this should include experience of successfully leading medicines through P3 file launch and early lifecycle

• 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 of the development manufacture commercial filing review and approval and clinical and commercial supply of small molecule biopharm or CGT medicines and the associated regulatory & quality standards; this should include device development & marketing requirements US EU China & Japan development marketing & launch requirements lifecycle CMC/SC changes & commercial compliance & quality standard-

• 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.

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

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 were 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.

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