Senior CMC Project Manager

  • Location

    United Kingdom
  • Salary

  • Job Type

  • Functions

    Technical Operations

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.


  • 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.


  • 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.

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