Role OverviewThe Senior Director, CMC Technical Lead is a senior individual-contributor role responsible for the technical integrity of the drug product and for connecting the technical narrative across Analytical Development, Process Development, MSAT, Quality Control, and Quality Assurance.
What You Will Do
Translating Neurogene’s deep AAV manufacturing and analytical expertise into a coherent, inspection-ready regulatory story.
Why It Might Be a Fit
This role owns the integrated control strategy and the technical narrative of Module 3, and is accountable for their scientific defensibility as the lead AAV gene therapy program advances through Process Performance Qualification (PPQ), BLA preparation, and commercial launch.
Requirements
- Ph.D. in a relevant field (e.g., Chemical Engineering, Biotechnology, Biochemistry, or related field)
- 10+ years of experience in CMC Technical Lead or similar roles
- Proven track record of success in leading cross-functional teams and managing complex technical projects
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