Senior Manager of CMC

Barrington James Limited; Greater London; On-site; GBP 90,000 - 130,000; Full time

Job summary

Barrington James Limited is supporting a UK-based clinical-stage biotechnology company to appoint a Senior Manager, CMC Operations. The role is hands-on and senior, providing operational leadership across development, manufacturing and commercial readiness.

You will coordinate CMC workstreams, manage external CDMOs/CROs and drive programmes against regulatory, quality and budget requirements, while collaborating with Quality, Regulatory Affairs and Clinical Operations.

Qualifications

• Strong CMC experience in biologics or biopharma development.
• Experience guiding programmes from early development to commercial readiness.
• Experience in CDMO, CRO and vendor management.
• Led cross-functional teams across QA, Regulatory Affairs and Clinical Ops.

Responsibilities

• Coordinate CMC workstreams across process development, analytics, transfer and manufacturing.
• Manage external CDMOs, CROs and vendors to stay on track with regulatory, quality and budget goals.

Skills

CMC Operations

Biologics/biopharma

Program management

Vendor management

Cross-functional leadership

Job description

I'm supporting a UK-based clinical-stage biotechnology company with the appointment of a Senior Manager, CMC Operations.

This is a senior, hands-on role for someone with broad biologics CMC experience who can provide operational leadership across development, manufacturing and commercial readiness.

The position will work closely with the Head of CMC and take responsibility for coordinating multiple CMC workstreams across process and formulation development, analytical development, technical transfer, manufacturing, validation, stability and clinical supply. You will also play a key role in managing external CDMOs, CROs and specialist vendors, ensuring programmes remain on track against technical, regulatory, quality and budgetary requirements.

Key experience required:

• Strong CMC experience within biologics or biopharmaceutical development
• Experience taking programmes from early development towards Phase III and commercial readiness
• Strong CMC programme and project management experience
• Extensive CDMO, CRO and vendor management experience
• Broad understanding of process development, analytical development, manufacturing, tech transfer and validation
• Experience contributing to CMC regulatory documentation and submissions
• Strong cross-functional experience across Quality, Regulatory Affairs and Clinical Operations
• Previous people leadership experience
• Experience working in a lean, fast-paced biotech environment

Experience across modalities including DNA, mRNA, recombinant proteins, antibodies or cell-based therapies would be particularly relevant.