At a Glance
- Tasks: Lead the development and delivery of innovative medicines from concept to launch.
- Company: Join GSK, a global biopharma leader dedicated to improving health.
- Benefits: Enjoy a competitive salary, hybrid work model, and opportunities for professional growth.
- Other info: Dynamic role with excellent career advancement opportunities in a collaborative environment.
- Why this job: Make a real impact on patients' lives by leading cutting-edge medicine development.
- Qualifications: PhD or BsC in life sciences with significant CMC experience required.
The predicted salary is between 100000 - 150000 £ per year.
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.
- 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.
- 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 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.
- 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?
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.
GSK is an Equal Opportunity Employer.
Small Molecule CMC Leader - Senior Director in Ware employer: Gsk
GSK is an exceptional employer located in Greater London, offering a dynamic and inclusive work environment that fosters innovation and collaboration. As a Senior FinOps Product Manager, you will have the opportunity to drive impactful projects while benefiting from robust employee growth opportunities and a culture that values diverse perspectives. With a commitment to professional development and a focus on agile methodologies, GSK empowers its employees to thrive in their careers while contributing to meaningful advancements in cloud financial management.
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We think this is how you could land Small Molecule CMC Leader - Senior Director in Ware
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We think you need these skills to ace Small Molecule CMC Leader - Senior Director in Ware
Some tips for your application 🫡
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How to prepare for a job interview at Gsk
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Gsk that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
