At a Glance
- Tasks: Lead the development and launch of innovative medicines in a dynamic environment.
- Company: Join GSK, a global leader in pharmaceuticals with a commitment to diversity.
- Benefits: Enjoy a hybrid working model, competitive salary, and opportunities for professional growth.
- Other info: Work in a collaborative team and engage with senior decision-makers.
- Why this job: Make a real impact on healthcare by driving projects from concept to commercialisation.
- Qualifications: Extensive experience in CMC, strong leadership skills, and a background in Life Sciences.
The predicted salary is between 55000 - 70000 £ per year.
Position Summary
Lead the development, industrialisation, and lifecycle delivery of the assigned physical medicine (small molecule or oligonucleotide) from Commit to Phase 2 (C2P2) through to commercial launch, including global file preparation, launch readiness, and post‑launch lifecycle activities.
Responsibilities
- Engage with the medicine 6–12 months prior to C2P2 to prepare plans, resources, and budgets.
- Define the medicine development strategy and commercial vision with the Medicine Development Leader and team.
- Generate options and recommendations for Phase 3 (P3) development, supply, and global regulatory filings that balance time, cost, resources, and risk.
- Lead the execution of Product Performance Qualification (PPQ), Continuous Process Verification (CPV), and PAI readiness.
- Support global file, review, and launch readiness; oversee packaging, plus post‑launch needs and lifecycle projects.
- Communicate the physical product perspective to senior decision makers and secure timely decisions through governance.
Qualifications and Skills
- Extensive experience in pharmaceuticals, CMC, and Supply Chain.
- Strong background in Chemistry, Life Sciences or Bio/chemical engineering.
- Demonstrated project leadership of multi‑disciplinary matrix teams in a global biopharmaceutical environment.
- Knowledge of late‑phase CMC/supply‑chain development and commercialisation.
- Experience with global CMC regulatory requirements and technology transfer processes.
- Advanced degree (PhD, MBA) or equivalent experience is preferred.
- Track record of leading through complexity, managing uncertainty, and enabling high‑quality decision making across senior stakeholders.
Work Location
Stevenage (UK), Ware (UK) or Upper Providence (USA); hybrid working model.
Application Closing Date
10 July 2026
Equal Opportunity Employer
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, sexual orientation, gender identity, pregnancy, parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.
CMC Leader (Director) in Stevenage employer: GlaxoSmithKline
GSK is an exceptional employer that fosters a collaborative and innovative work culture, particularly for the CMC Leader role in Stevenage or Ware. With a strong commitment to employee growth, GSK offers extensive training and development opportunities, ensuring that team members can thrive in their careers while contributing to meaningful advancements in pharmaceuticals. The hybrid working model provides flexibility, allowing employees to balance their professional and personal lives effectively.
