Job Description
*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, Chemi...