Vice President, CMC and Technical Operations

A typical mandate

The company develops an engineered enzyme replacement therapy for a rare lysosomal storage disorder. The program is in a pivotal study and manufacturing sits with an external CDMO. The next two years decide whether the process, supply chain and control strategy are ready for licensure.

What the role owns

• Lead process development, analytical development, manufacturing and supply chain
• Own the CDMO relationship, including technology transfer and PPQ campaign planning
• Set the control strategy, specifications and comparability plan for the commercial process
• Author and review BLA Module 3 content with regulatory CMC
• Build a second-source and drug product strategy that reduces supply risk
• Grow the technical operations team as the company moves toward licensure

What great candidates bring

• PhD in chemical engineering, biochemistry or a related field, or equivalent experience
• 15+ years in biologics CMC, including late-stage development and commercial readiness
• Direct experience with PPQ and BLA CMC sections, ideally through approval
• Strong CDMO management and technology transfer experience
• Working knowledge of ICH Q5E, Q6B and Q8 through Q11
• Experience with glycoproteins or enzyme therapies preferred

Why it matters

• Reports to the CEO as a member of the leadership team
• Meaningful equity ahead of a BLA
• Full ownership of the path to commercial manufacturing
• Hybrid schedule, with CDMO travel as needed