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
The Upstream Process Development group will focus on the planning, execution, and analysis of studies targeted to support Neurogene’s viral vector platformThe role will center on producing recombinant AAV vector preparations in for preclinical studies, toxicology batches, reference material, and clinical products. Job functions will includeroutine 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 expertise designing and implementing rAAV capsid and vector genome variants, and be comfortableproducing recombinant AAV vectors at small- to medium-scales, including purification, titer assessment, and quality control. 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 capsid engineering and the process development of AAV gene therapy products.
Experience working in gene therapy is preferred, and a genuine interest in the space is highly valued.
Accountabilities and Responsibilities
- Independently perform routine suspension cell culture (sampling, cell counting, passaging)
- Independently maintains and manages upstream equipment appropriately
- 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).
- 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
- Collaborates with pre-clinical, analytical development, quality control, and manufacturing on the planning of upstream process development project timelines
Essential Details
- Work Schedule
- Day shift; weekend/night availability as needed or specified by management
- Travel
- <5%
- Safety
- Is knowledgeable and complies with all company safety policies, rules and regulations.
- Maintain the confidentiality of proprietary company information
Minimum Requirements
- Education
- Minimum: BSc in a Biological Science/ Chemistry/ Chemical Engineering
- Experience
- Expertise in AAV gene therapy
- 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
- Knowledge & Skills
- Deep understanding of AAV bioprocessing
- 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
- An understanding of GMP operations is a plus
- 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
- Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance and results.
- Ability to track and measure performance against defined metrics.
- Self-starter with high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team.
- Someone who moves fast and decisively in a balanced manner, with a passion for the growing company.
- Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.
- 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