CMC Operations Lead - Biologics & Biotech

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

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.