Director, Manufacturing

4 weeks ago


Houston, United States Neurogene Inc. Full time

Director, Manufacturing – Neurogene Inc. Join to apply for the Director, Manufacturing role at Neurogene Inc. Overview 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. Responsibilities Provide strategic and operational leadership of GMP Manufacturing operations with responsibility for ensuring uninterrupted production of clinical and commercial gene therapy products. Lead, develop, and mentor a cross‑functional team of manufacturing staff and managers to deliver on production goals, operational excellence, and compliance. Serve as a key contributor to the manufacturing leadership team, ensuring alignment with overall company objectives and timelines. Act as primary manufacturing liaison with cross‑functional teams including Quality, Regulatory, Analytical Development, Supply Chain, and Process Development to support tech transfers, deviations, CAPAs, and continuous improvement initiatives. Drive implementation of lean manufacturing principles and quality by design (QbD) strategies to enhance process robustness and reduce variability. Oversee execution and review of batch records, ensuring compliance with cGMPs and internal quality standards. Support inspection readiness activities and directly interface with regulatory agencies and partners as required. Contribute to manufacturing strategy development, budgeting, headcount planning, capital projects, and new technology implementation. Oversee execution of the Process Performance Qualification (PPQ) strategy and associated manufacturing campaign, ensuring alignment with process validation plans, quality system requirements, and regulatory expectations. Represent Manufacturing in CMC regulatory submissions and participate in preparation of BLA/MAA filings. Ensure documentation is completed to meet quality systems requirements. Work with Quality Assurance to achieve and maintain GMP readiness and compliance in manufacturing. Participate in facility safety programs. Hire, train, and supervise direct reports, and encourage continuing education and development. Essential Details Work Schedule: Day shift (some off‑shift hours: early mornings, late evenings/nights, and weekends if necessary) Travel:


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