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.
Reporting to the Senior Scientist, Analytical Development, the Research Scientist, Analytical Development will play a critical role in ensuring analytical work is planned and executed consistent with supporting product development timelines for Neurogene’s product pipeline. The candidate will participate in activities related to analytical development and assay transfer to the Quality Control team and/or contractors and CDMOs. Furthermore, the incumbent will be independent, self-motivated, and have superior written/oral communication skills essential for success in this role at a rapidly growing start-up. The ideal candidate will have a proven track record of assay development and transfer into a GMP setting.
Accountabilities and Responsibilities
- Develop/implement in vitro potency assays using cell-based, flow cytometry and/or biochemical or enzymatic readouts.
- Develop/implement ELISA assays for protein quantification in cell lysates.
- Perform single-cell cloning and/or cell banking activities as needed to support program needs.
- Test process development and research samples in cell-based and biochemical assays.
- Enable/participate in/lead assay transfer activities to Quality Control group.
- Maintain electronic laboratory notebooks, present data to the team, and write analytical test methods and study reports.
- Interact with process development and quality control teams on a regular basis with an emphasis on teamwork and efficiency.
- 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.
- Work Schedule • Day shift
- Travel • 10-30%
- Is knowledgeable and complies with all company safety policies, rules, and regulations.
- Ensures all team members comply with safety policies, rules, and regulations.
- Education • PhD in Biochemistry, Cell Biology, or related field with 1-2 years of experience; or MS with 3-5 years of experience.
- Experience in a biotech industry environment highly preferred.
- Exceptional analytical scientists with a deep academic background will be considered.
- Prior experience in a Core Lab setting is a plus.
- Working knowledge of assay qualification/validation.
- Understanding of gene therapy principles, industry practices, and regulatory standards with the ability to apply these to GMP analytics.
- Cell-based assay development especially in plate-based format. Flow cytometry is a plus.
- ELISAs, protein-protein interaction, and enzymatic assay development.
- Protein methods like silver staining, Western blotting, and UV-based assessments.
- Gene therapy/AAV-specific experience is a plus (viral transductions, TCID50, functional titer assays).
- Demonstrated ability in problem-solving, excellent interpersonal skills, and the ability to handle and prioritize multiple tasks.
- 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.
- Organized approach to work, strong attention to detail with strong documentation and coordination practices.
- Working Conditions • Majority of the work is done in a laboratory.