Vice President, Management

About the Company

A well-funded, clinical-stage biologics company, with multiple programs across Phase 1 and Phase 2 and a recent Series C close, the company is transitioning from a pure development organisation into one with a clear commercial horizon. Pipeline focused on serious and rare disease across monoclonal antibodies and bispecific platforms.

A newly created VP of CMC position reporting directly to the CTO. Full ownership of CMC strategy across drug substance and drug product as the company moves its lead programs toward late stage and commercial readiness.

• Own and execute the end-to-end CMC strategy across the biologics pipeline from IND through BLA
• Lead tech transfer and process validation activities into CDMO partners
• Build and lead a high-performing CMC team across process development, analytical development and manufacturing sciences
• Drive regulatory CMC strategy and author/review Module 3 submissions for FDA and global agencies
• Manage CDMO relationships and oversee GMP manufacturing campaigns
• Partner closely with Clinical, Regulatory, Quality and Commercial teams to ensure CMC readiness at each program milestone
• Represent CMC at board level and with external partners and investors

• PhD in Biochemistry, Chemical Engineering or related discipline preferred
• 15+ years of biologics CMC experience with at least 5 in a senior leadership role
• Deep expertise across drug substance and drug product development for biologics
• Strong track record of IND and BLA submissions with FDA
• Experience managing CDMOs and leading late-stage tech transfer and PPQ activities
• Prior experience scaling a CMC function within a clinical-stage biotech
• Exceptional cross-functional leadership and stakeholder management skills