Senior director

Senior Director, CMC Lead – Gene Therapy

We’re partnering with a cutting-edge biotech organisation developing advanced gene therapies, now seeking a Senior Director, CMC Lead to drive strategy across their growing portfolio.

This is a pivotal leadership role where you will shape and execute global CMC strategy, guiding programmes from early development through to commercial readiness. You’ll work at the intersection of science, manufacturing, and regulatory, playing a key role in bringing innovative therapies to patients.

The Opportunity

As the CMC Lead, you will take ownership of all CMC activities across gene therapy programmes, acting as the strategic link between R&D, Regulatory, Quality, and Manufacturing.

You’ll lead complex development programmes spanning drug substance and drug product, ensuring alignment with global regulatory expectations and readiness for clinical and commercial supply.

Key Responsibilities

• Define and execute CMC strategy across gene therapy programmes from IND-enabling studies through to BLA and launch
• Act as the senior CMC lead and primary point of contact across all programmes
• Oversee development of viral vector drug substance and drug product, including process and analytical development
• Lead technology transfer from R&D into GMP manufacturing environments (internal and CDMO)
• Drive process characterisation, validation (PPQ), and continued process verification (CPV) strategies
• Ensure manufacturing readiness for clinical (Phase I–III) and commercial supply
• Develop and implement robust global supply strategies
• Lead CMC regulatory strategy, including IND and BLA submissions and interactions with global health authorities
• Collaborate cross-functionally with Regulatory, Quality, Clinical, and Operations teams
• Provide leadership across budgeting, resource planning, and external vendor oversight
• Mentor and develop a high-performing CMC team

What We’re Looking For

• Advanced degree (PhD preferred) in a relevant life sciences discipline
• Extensive experience (typically 12+ years) in CMC within biotech or pharma
• Proven leadership experience across clinical-stage or late-stage programmes
• Strong background in gene therapy, viral vectors, or advanced biologics
• Deep expertise across drug substance and drug product development
• Experience with upstream/downstream processing and fill/finish operations
• Demonstrated success supporting IND and BLA submissions (CMC sections)
• Strong knowledge of global regulatory requirements (FDA, ICH guidelines)
• Experience managing CDMOs, tech transfer, and manufacturing oversight
• Ability to lead complex, cross-functional programmes in a fast-paced environment

Why This Role?

• Lead CMC strategy for cutting-edge gene therapy programmes
• High-impact leadership role with visibility across the organisation
• Opportunity to influence programmes from early development to commercialisation
• Collaborative, science-driven environment with strong growth trajectory