Associate Scientist, Upstream Process Development

At Neurogene, we focus 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 are using 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 and fully operational GMP-capable manufacturing facility supports vector production from research through clinical grade and is designed for commercial-grade production. In addition, Neurogene is now trading on the NASDAQ Global Market. This transformative work is driven by our highly collaborative people and comes together to bring us closer to achieving our mission of turning devastating diseases into treatable conditions, to improve the lives of patients and their families. 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.

The Upstream Process Development group will focus on the planning, execution, and analysis of studies targeted to optimize Neurogene’s current viral vector platform for toxicology and clinical products. The role will center on mammalian and insect suspension cell culture – i.e routine cell expansion, cell screening, production of viral vector(s), small and pre-clinical material generation in large scale bioreactors, and filtration. Other job functions may include laboratory maintenance, procurement of essential consumables, and cross-collaborative assistance with downstream process development and manufacturing groups.

The ideal candidate will have experience in suspension cell culture, be comfortable in/willing to learn the independent execution of routine cell culture in shake flasks, and bioreactor operation(s). In addition, the ideal candidate will have knowledge and/or experience of the regulatory guidelines surrounding cGMP manufacture, a general understanding of viral vector bioprocessing, and/or experience or understanding of the process development of AAV gene therapy products.

Although experience working in gene therapy is not required, a genuine interest in the space is highly valued.

Accountabilities

• Perform routine suspension cell culture (sampling, cell counting, passaging).
• Assist in ensuring that upstream equipment is appropriately maintained and managed.
• Support upstream technology strategies in various platforms including shakes flasks, rocker, 2L, 3L, 10L, and 50L from the development stage, tech transfer, engineering runs, and GMP manufacturing ; Assist in and execute unit operations for development, toxicology, and GMP batches for viral vector production(s).
• Support continuous improvement strategies by assisting in experiment design and presentation of results to internal and external stakeholders; evaluation of new technologies and collaboration with vendors.
• Assist in the preparation of buffers/reagents ,bioreactor set-up (bench-top to 50L SUB), and sampling operations, monitoring of process performance, as well as cleaning and waste disposal to support process development operations.
• Ensuring adequate and appropriate inventory of materials and supplies, collaboration with supply chain, ordering materials.
• Draft, edit, and/or review data capture forms, batch production records, standard operating procedures or standard work elements for process development equipment and/or unit operations.
• Maintain responsible laboratory protocols, data capture, lab notebooks, and/or files using GDP.
• Support in the planning of upstream process development project timelines in collaboration with analytical development, quality control, and manufacturing.

Minimum Requirements

• BSc in a Biological Science/ Chemistry/ Chemical Engineering
• Experience in and understanding of operations within a biosafety cabinet, cell culture incubators, cell culture shaking platforms, centrifugation equipment, aseptic technique, and associated general cleaning procedures
• Experience with media preparations, monitoring cell culture, routine sampling, preparation, execution, and analysis of cell expansion
• Handling various sized shake flasks and small-scale bioreactors in a process development setting
• Experience using MS Office, Excel and basic cell kinetic analysis
• Large-scale bioreactor experience is a plus
• AAV bioprocessing and development is a plus
• Experience with cell line development is a plus
• Experience in a GMP environment is a plus
• Cell kinetics analysis (Doubling times, growth curves, viabilities, etc)
• Pilot-Scale filtration experience is a plus
• Must have a basic understanding of drafting and execution of Standard Operation Procedures and/or Standard Work Elements
• Basic understanding of AAV bioprocessing is a plus
• An understanding of GMP operations is a plus

Skills

• Must be able to function collaboratively in a team environment
• Demonstrate excellent time-management and forward-thinking skills
• Must display effective oral and written communication
• The candidate must be proficient in basic MS Office and Excel
• MFCS/SCADA software experience is a plus
• Ability to troubleshoot, solve problems, and think critically
• Desire to work in a PD/GMPW environment focusing on gene therapy viral vector bioprocessing
• Must be comfortable lifting 25lbs, frequently, and occasionally 50lbs

Work Environment

• Process development work may require time outside of normal business hours to plan, execute, and maintain experiments in order to meet the timelines set by management