Walker Cole International is currently supporting hiring for a CMC Manager. This exciting opportunity combines strategic oversight with hands-on leadership across drug development for mammalian-expressed biologics.

The position can be based at one of several UK or Ireland sites, offering hybrid flexibility.

Key Responsibilities of the CMC Manager:

*

Leading drug substance process development, validation, and regulatory submission.

*

Driving cross-functional CMC and internal optimisation programmes.

*

Leading tech transfer and lifecycle management activities.

*

Managing external collaborations and third-party relationships.

*

Contributing to regulatory filings and ensuring GxP compliance.

*

Mentoring scientific teams and embedding new technologies.

Key requirements for the CMC Manager position include:

*

Extensive experience in mammalian biologics development.

*

Strong CMC knowledge across the product lifecycle.

*

Proven record in regulatory documentation.

*

Experience leading cross-functional teams and technical projects.

Biologics | Drug Substance | CMC | Process Development | Tech Transfer | QbD | DoE | Sustainability | GxP | Regulatory