Senior CMC Project Manager

Location -London or Brighton (remote)

About the company

• A clinical phase biotechnology company focused on world leading infection prevention. The company has two late stage clinical programmes and an earlier preclinical pipeline.
• The successful candidate will be responsible for leading the manufacturing and testing a biologics portfolio. As well as Managing the CMC technical, quality, and regulatory aspects from development to Phase 3, through to BLA and commercialisation.

Duties

• Managing and oversee all technical, regulatory, quality aspects for Formulation, Analytical and Process Development.
• Design and manage stability studies and production and testing of batches (GMP/GLP)
• Oversee the selection and management of CDMO’s, proactively manage the CDMO relationship to ensure business and project objectives are met.
• Author and review technical and quality documents for internal use and for the CMC sections of regulatory filings, including INDs, IMPDs and BLAs.
• Maintain CMC project plans and timelines.

Experience

• BSc or above in Biological Sciences (or equivalent)
• 5+ years of experience in biologics manufacturing (including phase 3 BLA to commercialisation)
• Strong experience within a GMP environment
• Managing and working with supply contractors to deliver projects on time, adhering to budget.
• Strong experience within project management including strategic direction, operational logistics and detailed project plans.
• Strong interpersonal skills, team player and ‘get the job done’ mentality.

Please submit your resume to us for a private and confidential discussion about the opportunity.