CMC Manager
Posted 25 days ago
- Dunsop Bridge, Lancashire
- Permanent
- £60,000 to £75,000 /Yr
- Sponsored
- Expires In 3 days
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:
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Leading drug substance process development, validation, and regulatory submission.
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Driving cross-functional CMC and internal optimisation programmes.
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Leading tech transfer and lifecycle management activities.
*
Managing external collaborations and third-party relationships.
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Contributing to regulatory filings and ensuring GxP compliance.
*
Mentoring scientific teams and embedding new technologies.
Key requirements for the CMC Manager position include:
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Extensive experience in mammalian biologics development.
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Strong CMC knowledge across the product lifecycle.
*
Proven record in regulatory documentation.
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Experience leading cross-functional teams and technical projects.
Biologics | Drug Substance | CMC | Process Development | Tech Transfer | QbD | DoE | Sustainability | GxP | Regulatory
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