Overview
In this Senior Manager, CMC Operations role you will lead CMC-related activities across development, manufacturing and commercial readiness for a biologics-focused organization. You will coordinate multiple CMC workstreams, including process and formulation development, analytical development, tech transfer, manufacturing, validation, stability and clinical supply. You will manage external CDMOs, CROs and vendors to keep programmes on track with regulatory, quality and budget expectations. You’ll collaborate with the Head of CMC and cross-functional teams to drive programmes from early development toward Phase III and commercial readiness.
Responsibilities
- Coordinate multiple CMC workstreams across process/formulation development, analytical development, tech transfer, manufacturing, validation, stability and clinical supply
- Manage external CDMOs, CROs and specialist vendors to ensure programme progress
- Provide operational leadership to keep programmes aligned with regulatory, quality and budget requirements
- Collaborate with Head of CMC and cross-functional teams (Quality, Regulatory Affairs, Clinical Operations)
- Contribute to CMC regulatory documentation and submissions
Key requirements
- 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
- Cross-functional collaboration
- Stakeholder management
- Leadership and mentoring
- CMC development
- Process development
- Analytical development
Senior Manager of CMC in London employer: Barrington James
Barrington James is an exceptional employer that fosters a collaborative and innovative work culture, making it an ideal place for professionals in Epidemiology and Real-World Evidence. With a strong emphasis on employee growth, we offer tailored development opportunities and the chance to lead impactful projects across diverse therapeutic areas in the dynamic UK/Europe market. Join us to be part of a team that values flexibility, creativity, and meaningful contributions to healthcare advancements.
