*No applications outside of EU will be considered*
Summary
Lead CMC (Chemistry, Manufacturing, and Controls) activities to support the development and delivery of drug products from early stages through to commercialisation.
Key Responsibilities
Implement CMC strategies across the product lifecycle.
Manage cross-functional teams (e.g. process and analytical development).
Plan development activities, timelines, and manage risks.
Ensure compliance with global regulatory standards.
Work with external partners (CMOs, CROs) and internal teams like Quality and Regulatory.
Support regulatory submissions (IND, NDA, BLA) with clear documentation.
Represent CMC in project and governance meetings.
Manage budgets, resources, and forecasts.
Qualifications
10+ years of CMC experience, with an advanced degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or similar.
Experience with BOTH small molecules and biologics
Experience leading a BLA/IND filing
Stakeholder management skills and experience leading cross‑functional teams.
Strong knowledge of GMP and regulatory requirements.
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