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 a senior research associate/research scientist to support assay development, qualification, routine sample testing and analytical method transfer activities in support of our AAV therapeutic platform.
Neurogene is seeking a qualified and motivated candidate to join the Analytical Development Team. Reporting into the project leadership team, the Senior Research Associate/Research Scientist will provide expertise to a team responsible for developing, optimizing and qualifying analytical methods for product and process characterization and transferring analytical methods to QC. The candidate will ensure analytical work is planned and executed in a timely manner to support process development and Neurogene’s gene therapy product pipeline. The candidate will support work related activities for analytical development and technology transfer from strategic partners and to the Quality Control team and/or selected contractors and CROs. The selected candidate will have a proven track record of assay development, qualification and transfer into a GMP setting with superior written/oral communication skills essential for success in this key role in a rapidly growing start-up. Furthermore, the incumbent must be self-motivated and able to work both independently and within a collaborative team environment. The candidate will manage the design and workplan to establish analytical methods to support Neurogene’s clinical programs.
Primary Accountabilities, Duties, and Responsibilities
- Adapt and/or support development of suitable cGMP analytical methods for the characterization, in-process monitoring and stability testing of Neurogene’s Gene Therapy products. This will include, but is not limited to potency assays, titer assays, immunoassays and other assays as required by the increasing regulatory requirements for gene therapy products.
- Accountable to support established analytical methods to identify, measure and track CQAs for products in Neurogene pipeline.
- Stay current and connected in the rapidly-growing field of analytical and method development in cell and/or viral production and cell engineering.
- Accountable for the planning, resourcing and execution of all analytical development needs, in collaboration with the Analytical Development Senior Scientists.
- Perform analytical method 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
- Serve as a subject matter expert to key stakeholders to support company growth and to evaluate new analytical requirements and trends as needed. Effectively communicate development progress.
- Maintain good laboratory records using electronic laboratory notebook.
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
- Education: BS or MS in Biochemistry, Cell Biology, Virology or related field.
- Experience: At least 5 years of related experience in a biotech environment. Exceptional analytical scientist with a deep academic background will be considered. Prior experience in a QC setting is a plus.
- Knowledge •Working knowledge of cGMPs related to all aspects of Biologics manufacturing, including ICH Q7, ICH Q2 and FDA/EMA regulations related to cell/gene therapy and aseptic manufacturing of drug product.
- Specific analytical expertise and proven hands-on track record of method development or testing including but not limited to: cell-based assays with solution and image-based readouts, qPCR, digital droplet PCR, ELISA and SDS-PAGE/Western Blot.
- Demonstrated cell culture skills including cell-banking with excellent sterile technique
- 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.
- Basic understanding of bioprocessing is highly desirable to ease assay development and troubleshooting, assay transfer and implementation.
- Working Conditions: A majority of the work is done in a laboratory.