Senior CMC Manager – Biologics
Location: UK (flexible with travel as required)
Allerton Bishop is partnering with a global biopharmaceutical company to appoint a Senior CMC Manager to support their expanding pipeline of biologics. This is a key hire within the CMC function, offering the opportunity to take ownership of drug substance development and manufacturing strategy across late-stage clinical and commercial programmes.
In this role, you will work closely managing outsourced manufacturing activities with leading CDMOs and ensuring regulatory compliance throughout the development lifecycle. The position will suit a candidate with deep biologics CMC expertise, strong project leadership skills, and the ability to operate effectively in a cross-functional, global environment.
Key Responsibilities
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Lead and support CMC activities relating to biological drug substance development and production.
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Manage outsourced manufacturing with CDMOs, ensuring timelines, budgets, and quality standards are met.
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Collaborate across Quality, Regulatory, and Supply Chain functions to deliver successful project outcomes.
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Contribute to the development and implementation of CMC strategies to support regulatory submissions.
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Review and approve CMC documentation including protocols, reports, and submissions.
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As the Senior CMC Manager, you will provide technical expertise and guidance across biologics CMC activities.
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Monitor risks, identify mitigation strategies, and support long-term process improvement.
Candidate Profile
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Degree in Biotechnology, Biochemistry, Chemistry, or Biochemical/Chemical Engineering (advanced degree preferred).
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Work experience in CMC within biologics drug substance.
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Experience supporting late-stage clinical and commercial programmes highly desirable.
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Strong knowledge of drug substance development, process development, and outsourced manufacturing.
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Willingness to travel for business purposes.