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 Downstream Process Development Associate Scientist/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 Downstream PD Associate Scientist/Scientist will center on supporting the development of downstream purification processes of viral vectors. The Downstream Process Development Associate Scientist/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 upstream process development and analytical development personnel.
The ideal candidate will have experience in protein/virus purification, be comfortable in the independent execution of routine buffer preparation, sampling and basic understanding of chromatography and filtration-based purification methods. In addition, the ideal candidate will be familiar of the regulatory guidelines surrounding cGMP manufacture, a general understanding of viral vector bioprocessing, and/or experience in protein purification.
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 virus purification activities (buffer preparation, sampling, executing small scale purification runs) under the direction of the Senior Downstream 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
- Work Schedule: 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
- Experience in and understanding of basic lab operations for virus/protein harvest from bioreactors, knowledge of aseptic technique, and associated general lab upkeep and cleaning procedures
- Experience with buffer preparation, routine sampling, preparation, execution, and analysis of buffers using standard measure such as pH, conductivity, osmolality.
- Basic understanding of chromatography and filtration-based purification methods.
- Experience with AKTA chromatography system and a plus
- AAV bioprocessing and development is a plus
- Minimum: BSc in a Biological Science
- Virus/Protein purification methods
- 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
- Ability to troubleshoot, solve problems, and think critically
- Desire to work in a PD/GMP environment focusing on gene therapy viral vector bioprocessing
- Must be comfortable lifting 25lbs, frequently, and occasionally 50lbs
- Working Conditions
- The majority of the work is performed in a research lab.