Neurogene exists to provide medicines to cure or substantially improve the lives of families and people living with neurologic impairment. The day to day difficulty of caring for someone with a devastating neurologic disorder is a heavy burden for families, and we imagine a world where families no longer have to hear the message that their rare disease has no treatment. As an employee of Neurogene, you will be helping to make this dream a reality, and part of a culture of people in a start-up environment on a mission to make the world a better place!
The Upstream Process Development Scientist will focus on assisting current process development staff in the planning, execution, and analysis of studies targeted to optimize Neurogene’s current viral vector platform for toxicology and clinical products. The role of Upstream PD Scientist will center on suspension cell culture – i.e routine cell expansion, production of viral vector(s), small and large scale bioreactors, and filtration. The Upstream Process Development Scientist may be asked to assist in and execute toxicology and production batches in non-GMP and GMP environments in conjunction with current industry and/or academic collaborators. Other job functions may include laboratory maintenance, procurement of essential consumables, and cross-collaborative assistance with downstream process development.
The ideal candidate will have experience in suspension cell culture, be comfortable in the independent execution of routine cell culture in shake flasks, and possess a good understanding of 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 in cell line development.
Although experience working in gene therapy is not required, a genuine interest in the space is highly valued.
Primary Accountabilities, Duties, and Responsibilities
- Perform routine suspension cell culture (Media preparation, sampling, cell counting, passaging) under the direction of the Senior Upstream Process Development Scientist.
- Perform routine cell screening for product-specific cell line development under the direction of the Senior Upstream Process Development Scientist.
- Assist in and execute unit operations for development, toxicology, and GMP batches for viral vector production(s).
- Assist in the preparation of buffers/reagents or unit operation execution under the direction of the Senior Downstream Development Scientist
- Assist in the preparation and procurement of raw materials, consumables, inventory control as well as cleaning and waste disposal to support process development operations.
- 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 computer detected records.
Essential Job Functions
- Day shift
- Travel <5%
- Is knowledgeable and complies with all company safety policies, rules and regulations.
- Maintain the confidentiality of proprietary company information
Minimum Required Qualifications/Skills
- Education Minimum:
- BSc in a Biological Science with 4 yrs industry experience
- 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 is a must.
- Experience using MS Office and basic cell kinetic analysis
- Large-scale bioreactor experience is a plus
- AAV bioprocessing and development is a plus
- Experience in a GMP environment is a plus
- Cell kinetics analysis (Doubling times, growth curves, viabilities, etc)
- 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
- 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
- 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
- Working Conditions
- 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