What are the responsibilities and job description for the Director, GMP Quality Assurance position at Neurogene Inc?
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.
Position Overview
The applicant will be a team player in a small company environment in this highly cross-functional role. Reporting to the Executive Director, Quality Assurance, this person will be responsible for providing leadership and managing all the quality systems for Neurogene’s manufacturing operations. The applicant must have a strong working knowledge of phase-appropriate GMP requirements and the ability to present and defend the Quality System to regulatory agencies. This role will collaborate across the company and support the filing of investigational new drug applications and BLA submissions and be part of the transformative shift the company is making as we move from the pre-clinical stage to IND enabling studies and to accelerated clinical development.
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