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! Neurogene is seeking an experienced senior Upstream Process Development Scientist to drive the development, characterization, scale-up and transfer to advance viral gene therapy production processes for Neurogene’s adeno-associated virus pipeline of therapies.
Reporting into the Head of Process Development, the Senior Upstream Process Development Scientist plays a critical role in ensuring upstream process development work is planned and executed consistent with timelines for Neurogene’s product pipeline. The candidate will manage all work activities related to upstream process development and technology from academic collaborators and to the manufacturing team and/or selected contractors and CDMOs. This hands-on technical leadership role in a rapidly-growing start up requires a thorough grasp of mammalian AAV production platforms to serve as the key driver of Neurogene’s upstream manufacturing processes. The selected candidate will be able to design, characterize and optimize a robust, scalable, productive upstream process for the generation of therapeutic AAV products in the pipeline. The selected candidate will have a demonstrated track record of successfully advancing AAV products from discovery to clinical stages, along with superior written/oral communication skills. Furthermore, independence and self-motivation, ability to anticipate challenges in scale-up to commercially viable volumes will characterize the ideal candidate.
Primary Accountabilities, Duties, and Responsibilities
- Design, develop and implement scalable, GMP-suitable upstream operations in single-use systems including cell banking, seed expansion and feed strategy, vector production, and recovery unit operations, in order to prepare suitable material for downstream purification in high yield.
- Identify and advance the understanding of critical process parameters for the continuous optimization and robust manufacture of AAV pipeline products.
- Able to identify, assess and implement industry-leading trends to ensure maximum process efficiencies
- Accountable for the planning, resourcing, and management of all upstream development needs, in collaboration with the Head of Process Development.
Responsible for the successful tech transfer of the developed upstream process to the manufacturing team.
- Serve as a subject matter expert for key stakeholders to support company growth and to evaluate new upstream process requirements and trends as needed. Effectively communicate direction and progress.
- Collaborate closely with analytical development and downstream development functions to identify critical quality attributes and process performance parameters for AAV production. Evaluate and trend in-process and analytical data.
- Author technical reports, tech transfer documents, supporting technical sections of IND submission, as needed
- Efficiently manage shifting priorities as company needs evolve and ability to prioritize important tasks in a fast-paced dynamic environment, where cross-functional communication is critical to success
- Stay current and connected in the rapidly-growing field of viral vector process development, and attend outside meetings/conferences yearly, presenting whenever possible.
Essential Job Functions
- Work Schedule: Day shift
- Travel: <10%
- Is knowledgeable and complies with all company safety policies, rules and regulations.
- Ensure that all team members comply with safety rules and regulations.
Minimum Required Qualifications/Skills
- Working Conditions
- A majority of the work is performed in the laboratory.
- Ph.D. in (Bio)Chemical engineering, Cell Biology, Virology or related field.
- At least 3 years of related experience preferably in a biotech environment. Knowledge of statistical process control will characterize the exceptional candidate
- Working knowledge of global cGMPs related to all aspects of biologics manufacturing, related to cell/gene therapy and aseptic manufacturing of drug product. Prior experience with GMP documentation including batch records, deviations is a plus.
- Understanding of gene therapy principles, industry practices, and regulatory standards with ability to apply these to GMP analytics.
- Solid knowledge of single-use stirred tank bioreactor systems, clarification/depth filtration, dead-end filtration, UF/DF, with prior experience in vector manufacturing with mammalian production platforms.
- Demonstrated strong aptitude in problem solving, excellent interpersonal skills and the ability to prioritize multiple tasks. Must be able to act decisively.
- Ability to work both independently and collaboratively in a team structure with the ability to adapt to changing priorities. Holds self and others accountable for achieving collective goals.
- Excellent verbal and written communication skills, including the ability to influence others and lead complex projects.
- Strong attention to detail with strong documentation and project management practices.