What are the responsibilities and job description for the MSAT Engineer position at Neurogene Inc.?
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. 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
This position will be part of the Manufacturing Science and Technology (MSAT) function at Neurogene. The role of MSAT Engineer will bring on board diverse experiences in biologics processing and will play a key role in supporting, advancing, and optimizing Viral Vector production processes, with the goal of producing transformative therapies.
Accountabilities and Responsibilities
- Collaborate with cross-functional teams to support process transfers, process scale-up, and implementation of process improvements
- Participate in developing strategies to ensure process manufacturability and scalability, robust process design, optimization and advancement of viral vector programs to commercial stage
- Provide technical support for manufacturing process execution, conduct or support deviation investigations, utilize efficiently root cause analysis tools, implement corrective actions and prevention plans, and necessary change controls
- Conduct process data gathering and data analysis to drive manufacturing process improvements and maximize process consistency and manufacture of product that meets predetermined specifications
- Author, review and / or revise technical documents such as plans, protocols, summary reports, risk assessments, procedures
- Knowledge of industry trends and adherence to cGMP practices and regulatory requirements
Essential Details
Minimum Requirements
Work Environment
Much of the work is done in a private office, warehouse or manufacturing environment. The manufacturing environment is a cleanroom where appropriate gowning is required to be worn. Work may involve high energy hazards, such as steam, high pressure gases, flammable materials, high temperature liquids and high voltages, cryogenic operations, loud machinery and chemical hazards such as strong acids and bases.
