Director, Manufacturing Science and Technology

Company BackgroundThe 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 OverviewWe are seeking a talented and motivated MSAT (Manufacturing Science and Technology) professional to join our dynamic team. As an MSAT professional, you will play a crucial role in the advancement and optimization of biotechnology processes, ensuring the safe and efficient production of life-changing medicines.Accountabilities and ResponsibilitiesCollaborate with cross-functional teams to support process transfers, process scale-up, process improvements, and troubleshooting activitiesDevelop and execute experiments to evaluate and optimize manufacturing processesDevelop strategies for process characterization and process validation as programs approach commercializationConduct data gathering, data analysis and interpret results to drive manufacturing process improvements and maximize product consistency and qualityAuthor, review, and revise technical documents, such as protocols, reports, and standard operating procedures (SOPs)Provide technical expertise to resolve deviations, investigations, and out-of-specification (OOS) eventsSupport technology transfers by providing technical oversight, participating in product and process risk assessments, and ensuring compliance with regulatory guidelinesAssist in the qualification and validation of new equipment and processesStay current with industry trends and advances in biotechnology, sharing knowledge and suggesting innovative solutionsEssential Details - Manufacturing ONLYWork ScheduleDay shiftTravel