Senior Director, CMC Technical Lead

Company Background

The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to target tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile.

The Company’s novel and proprietary EXACT transgene regulation platform technology allows for the delivery of therapeutic levels while limiting transgene toxicity associated with conventional gene therapy.

The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to target tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile.

The Company’s novel and proprietary EXACT transgene regulation platform technology allows for the delivery of therapeutic levels while limiting transgene toxicity associated with conventional gene therapy.

Neurogene has constructed a state-of-the-art gene therapy manufacturing facility in Houston, Texas. CGMP production of NGN-401 was conducted in this facility and will support pivotal clinical development activities. This transformative work is driven by our highly collaborative people who come together each day to bring us closer to achieving our mission. As an employee of Neurogene, you will be part of building a culture that honors patient and caregiver mindsets and nurtures innovation, creative problem solving and a strong sense of purpose.

The 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. Reporting to the SVP, Technical Operations, 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.

This position addresses a critical BLA-preparation capability need: translating Neurogene’s deep AAV manufacturing and analytical expertise into a coherent, inspection-ready regulatory story. The role works horizontally across established CMC functions—integrating the technical artifacts that span those functions rather than managing the functions themselves—and chairs the CMC Technical Review Board, the governance forum where cross-functional BLA technical decisions are made and recorded.

It partners closely (dotted line) with Regulatory CMC, which retains ownership of filing strategy and health-authority interactions.

• Own the integrated control strategy — serve as the single technical owner of the end-to-end control-strategy narrative, connecting critical quality attributes (CQAs) to critical process parameters (CPPs), in-process controls, and release and stability specifications, with clearly documented criticality logic for each linkage.
• Integrate the technical story across functions — connect the scientific narrative across Analytical Development, Process Development, MSAT, Quality Control, and Quality Assurance so that Module 3 presents one internally consistent technical argument.
• Craft the BLA / Module 3 technical narrative — author and integrate the technical content and scientific justification for CTD Module 3 sections (e.g., S.2.6, P.2, specification and process-characterization justifications), ensuring the process…