CMC & Technical Operations
Vice President, CMC and Technical Operations
Take a recombinant enzyme from clinical supply to commercial-ready manufacturing. You will own process validation, the CDMO network and the CMC sections of a future BLA.
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
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