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!
Reporting into the Head of Process Development, the Senior Analytical Development Scientist plays a critical role in ensuring analytical work is planned and executed consistent with product development timelines for Neurogene’s product pipeline. The candidate will manage all work activities related to analytical development and technology transfer from academic collaborators and to the Quality Control team and/or selected contractors and CDMOs. The selected candidate will have a proven track record of assay development and transfer into a GMP setting, demonstrated leadership experience, and superior written/oral communication skills essential for success in this key role in a rapidly growing start-up. Furthermore, the incumbent will be highly independent and self-motivated, able to anticipate the challenges in understanding critical product quality attributes (CQAs). The candidate will manage the design and workplan to establish all analytical methods services and support to develop Neurogene’s programs.
- Stay current and connected in the rapidly-growing field of analytical and method development in cell and/or viral production and cell engineering, and attend several outside meetings/conferences, presenting Neurogene data at appropriate intervals.
- Accountable to establish analytical methods to identify, measure and track CQAs for products in Neurogene pipeline.
- Adapt and/or develop and establish suitable cGMP analytical methods for the characterization, in-process monitoring, and stability testing of Neurogene’s products. This will include, but is not limited to, potency assays, titer assays, and other assays as required by the increasing regulatory requirements for gene therapy products.
- Accountable for the planning, resourcing, and management of all analytical development needs, in collaboration with the Head of Process Development.
- Serve as a subject matter expert for key stakeholders to support company growth and to evaluate new analytical requirements and trends as needed.
- Effectively communicate direction and progress.
- Lead and/or perform assay qualification and validation activities as required by cGMPs and company approaches and enable the tech transfer of the methods into the Quality Control team.
- 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
- Education, Ph.D. in Biochemistry, Cell Biology, or related field.
- Experience, At least 5 years of related experience preferably in a biotech environment. Exceptional analytical scientists with a deep academic background will be considered. Prior experience in a Core Lab setting is a plus.
- Travel, 10-30%
- Working knowledge of global cGMPs related to all aspects of Biologics manufacturing, including ICH Q7 and FDA/EMA regulations related to cell/gene therapy and aseptic manufacturing of drug product.
- Understanding of gene therapy principles, industry practices, and regulatory standards with ability to apply these to GMP analytics.
- Demonstrated strong ability 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. 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 coordination practices.
- Specific analytical expertise and proven track record of development including but not limited to: qPCR, ddPCR, NGS, cell-based assays, ELISA, SDS-PAGE/Western, HPLC a plus
- Basic understanding of bioprocessing is highly desirable to ease: assay development and troubleshooting, assay transfer and implementation