Senior Manager of CMC

I'm supporting a UK-based clinical-stage biotechnology company with the appointment of a Senior Manager, CMC Operations.

This is a senior, hands-on role for someone with broad biologics CMC experience who can provide operational leadership across development, manufacturing and commercial readiness.

The position will work closely with the Head of CMC and take responsibility for coordinating multiple CMC workstreams across process and formulation development, analytical development, technical transfer, manufacturing, validation, stability and clinical supply. You will also play a key role in managing external CDMOs, CROs and specialist vendors, ensuring programmes remain on track against technical, regulatory, quality and budgetary requirements.

Key experience required:

• Strong CMC experience within biologics or biopharmaceutical development
• Experience taking programmes from early development towards Phase III and commercial readiness
• Strong CMC programme and project management experience
• Extensive CDMO, CRO and vendor management experience
• Broad understanding of process development, analytical development, manufacturing, tech transfer and validation
• Experience contributing to CMC regulatory documentation and submissions
• Strong cross-functional experience across Quality, Regulatory Affairs and Clinical Operations
• Previous people leadership experience
• Experience working in a lean, fast-paced biotech environment

Experience across modalities including DNA, mRNA, recombinant proteins, antibodies or cell-based therapies would be particularly relevant.