Manufacturing Associate - GMP - Houston
About the Company
Neurogene focuses on bringing life-changing genetic medicines to patients and families affected by rare, devastating neurological diseases. Our clinical-stage company is developing NGN-401 for the treatment of Rett syndrome and NGN-101 for the treatment of CLN5 Batten disease. We use our proprietary EXACT transgene regulation technology and internal expertise to develop novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. Our wholly owned, fully operational GMP-capable manufacturing facility supports vector production from research through clinical grade and is designed for commercial-grade production. Neurogene is now trading on the NASDAQ Global Market.
As an employee, 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.
About the Role
The Manufacturing Associate will produce gene therapy products at Neurogene’s GMP viral vector manufacturing facility in Houston. This role will help maintain an uninterrupted supply of materials for clinical trials. The level of the associate position will be determined based on relevant experience.
Responsibilities
- Operate manual, semi-automated, and automated equipment in support of routine production of pre-clinical and clinical biopharmaceuticals.
- Perform large-scale cell culture using single-use disposable bioreactor systems.
- Conduct viral vector purification with process-scale chromatography equipment.
- Prepare buffer solutions.
- Stage equipment and raw materials in production suites.
- Assist in other production-related activities such as validation, data collection, inventory management, and maintenance of process equipment.
- Perform cleaning of facility and unit process equipment.
- Write and review SOPs and change control documents for manufacturing work areas.
- Ensure proper documentation is completed to meet quality systems requirements.
- Participate in facility safety programs.
- Resolve technical problems via internal teams and external sources such as vendor support.
Additional responsibilities for advanced roles include:
- Author technical documentation such as summary reports.
- Lead project meetings.
Requirements
- Associate’s Degree in Biology, Biotechnology, Biomanufacturing, or related science field OR Bachelor’s in Biology, Biotechnology, or related science field.
- Preferred but not required: Industrial experience in biopharmaceutical production in a GMP environment.
- Preferred but not required: Experience operating GMP Upstream and Downstream equipment and processes such as Bioreactors, Sterile Operations Under a Biosafety Cabinet, Chromatography Skids, and Tangential Flow Filtration.
Skills & Knowledge
- Understanding of complex process equipment and instrumentation.
- Working knowledge of GMP.
- Good aseptic technique.
- Able to perform procedures according to written guidelines.
- Able to develop or revise procedures when required.
- Able to perform repetitive tasks such as pipetting.
- Able to work within a manufacturing clean room (up to ISO 5 & Grade A) following training.
- Good basic computer skills.
- Interact effectively with staff members from multiple levels and departments.
- Ability to lift 50 lbs, assisted.
Work Environment
The majority of work is done in a manufacturing clean room environment. Work may involve high-energy hazards, such as high-pressure gases, flammable materials, cryogenic operations, and chemical hazards such as strong acids and bases. In some areas, gowning (e.g., coveralls, face mask, shoe covers, hair and beard nets) will be required.
Day shift, with some weekend work required. Travel is less than 10%.