Head of CMC Development

51786
  • Switzerland, Switzerland
  • Permanent
*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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