Senior Manager of CMC

Barrington James; Greater London; Hybrid; GBP 120,000 - 180,000; Full time

Job summary

A UK-based clinical-stage biotechnology company seeks a Senior Manager, CMC Operations to lead cross-functional CMC activities across development, manufacturing, and commercial readiness. You will coordinate multiple CMC workstreams, oversee analytic development, tech transfer, and validation, and drive timelines and quality across external CDMOs and CROs.

The role requires broad biologics CMC experience, strong project management, and leadership in a lean, fast-paced biotech environment.

Qualifications

• Strong CMC experience within biologics or biopharmaceutical development.

Responsibilities

• Coordinate multiple CMC workstreams across process and formulation development, analytical development, tech transfer, manufacturing, validation and clinical supply.
• Manage external CDMOs, CROs and vendor relationships to keep programmes on track against technical, regulatory, quality and budgetary requirements.
• Collaborate with Head of CMC and cross-functional teams (Quality, Regulatory Affairs, Clinical Operations) to align on milestones and deliverables.

Skills

CMC management

Project management

Vendor management

Cross-functional collaboration

Biologics CMC

Regulatory submissions support

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.