At Neurogene, we are working to provide medicines to improve the lives of neurologically impaired children and their families. We envision a world in which all families have access to genetic medicines, even if the disorder is exceedingly rare. For children, our goal is to enable them to have a healthier future. For families, we want to make their lives better by easing the challenges of caring for someone with a devastating neurological disorder. 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 whose mission is to improve the lives of the patients we serve and make the world a better place.
Neurogene is seeking a Research Associate, Analytical Development, to support assay development and qualification, analytical support for Process Development activities, and assay transfer activities in support of our AAV therapeutic programs. The Research Associate 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 perform 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 different laboratory techniques and written/oral communication skills essential for success in this key role in a rapidly growing start-up; experience with analytical method development, analytical method transfer/qualification, familiarity with the principles of GLP and/or GMP are preferred. Furthermore, the candidate will be highly independent and self-motivated, and be able to anticipate the challenges in understanding critical product quality attributes (CQAs).
Accountabilities and Responsibilities
- Ability to perform analytical methods to measure and track CQAs for products in the Neurogene pipeline.
- Support the development of suitable analytical methods for the characterization, in-process monitoring, and stability testing of Neurogene’s products by following all standard procedures and protocols for laboratory testing. This will include, but is not limited to, conducting molecular biology assays for gene therapy products.
- Support the day-to-day analysis of samples generated by Process Development and/or CDMOs for Neurogene’s products. The individual will focus on ddPCR, qPCR, and ELISA methods.
- Ability to prepare various solutions and reagents that support analytical methods. Maintain equipment and assist in organizing and ordering laboratory supplies.
- Ensure that all safety guidelines are followed strictly at all times and maintain a clean and orderly environment.
- Support cGMP assay qualification and validation activities and support the technical transfer of the methods into the Quality Control team.
- Efficiently manage shifting priorities as company needs evolve and prioritize important tasks in a fast-paced dynamic environment, where cross-functional communication is critical to success
- Work Schedule – Day shift
- Travel – <25%
- Is knowledgeable and complies with all company safety policies, rules and regulations.
- Ensure that all team members comply with safety rules and regulations.
- Bachelor’s Degree in Biochemistry, Cell Biology, or related field.
- At least 2 years of related laboratory experience, preferably in a biotech environment. A background in ddPCR, and/or qPCR, and immunohistochemistry is preferred.
- Working knowledge of GLP practices and fundamentals of molecular biology.
- Basic understanding of analytical method development, troubleshooting analytical methods, and assay transfer, qualification, and validation is highly desirable.
- Demonstrated ability in problem solving, excellent interpersonal skills and the ability to prioritize multiple tasks.
- Aseptic/sterile laboratory techniques critical to the success of molecular biology methods.
- 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.
- Must be detail oriented and have excellent documentation and coordination practices.
- Working Conditions
- A majority of the work will be performed in a laboratory.