CMC Strategy & Manufacturing Leader

Barrington James; Oxford; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading company is seeking a Chemistry, Manufacturing and Controls (CMC) Lead to oversee activities for its biologics pipeline. This role involves managing internal labs and external partnerships, ensuring compliance with global regulatory standards, and leading project delivery in a dynamic biotech environment.

Qualifications

• Strong CMC leadership experience in biologics.
• Proven track record in GMP manufacturing and regulatory submissions.
• Experience managing CDMOs and scientific teams.

Responsibilities

• Define and execute CMC strategy across analytical and process development.
• Manage GMP manufacturing and quality compliance.
• Lead technical problem-solving and project delivery.

Skills

Leadership

Project Management

Communication

Education

MSc/PhD in a relevant life science discipline

Job description

5 days ago Be among the first 25 applicants

Chemistry, Manufacturing and Controls (CMC) Lead to direct activities for its biologics pipeline. This role will oversee internal labs and external CDMO partnerships, driving development from early-stage through to late-stage clinical supply.

Key Responsibilities

• Define and execute CMC strategy across analytical, formulation, and process development.
• Manage GMP manufacturing, IMP supply chain, and quality compliance.
• Oversee regulatory documentation for clinical submissions.
• Lead technical problem-solving, risk mitigation, and project delivery.
• Build and manage internal teams and external vendor relationships.
• Ensure all manufacturing and documentation meet global regulatory standards.

Candidate Profile

• Strong CMC leadership experience in biologics (e.g., peptides, recombinant proteins, antibodies).
• Proven track record in GMP manufacturing, clinical supply, and regulatory submissions.
• Experience managing CDMOs and internal scientific teams.
• Excellent cross-functional communication and project management skills.
• MSc/PhD in a relevant life science discipline or equivalent industry experience.
• Comfortable working in dynamic, fast-paced biotech environments.
• UK work eligibility required.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Sales and Science

• Industries

  Research Services

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