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 part of a culture helping to make this dream a reality, collaborating with 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 into the Executive Director, Analytical Development, the Asssociate Director, Molecular Biology Team Lead, plays a critical role in ensuring analytical work is executed consistent with product development timelines for Neurogene’s product pipeline. The candidate will support 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.
Accountabilities and Responsibilities
- Stay current and connected in the rapidly-growing field of analytical and method development in AAV titer and purity determination, and attend several outside meetings/conferences, presenting Neurogene data at appropriate intervals.
- Establish and lead molecular biology team to support Neurogene’s growing pipeline
- Supports the establishment of analytical methods to identify, measure and track CQAs for products in Neurogene pipeline with a focus on ddPCR (including duplex assays).
- 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, ddPCR titer assays, alkaline DNA gels, HCDNA and other assays as required by the increasing regulatory requirements for gene therapy products.
- Serve as a subject matter expert for key stakeholders to support company growth and 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 able to prioritize important tasks in a fast-paced dynamic environment, where cross-functional communication is critical to success.
Essential Job Details
- Work Schedule
- Day shift
- Knowledgeable and complies with all and ensures all team members comply with company safety policies, rules, and regulations.
- Bachelor’s Degree in Biochemistry, Cell Biology, or related field.
- Minimum 8 years of related experience preferably in a biotech environment.
- Minimum 3 years ddPCR experience (assay development qualification, duplex ddPCR).
- Minimum 2 years people management experience.
- Exceptional analytical scientists with a deep academic background will be considered.
- 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.
- Team building and leadership skills.
- 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/RT-qPCR, ddPCR, NGS, alkaline DNA gels, 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.
- Working Conditions
- Majority of the work is done in a laboratory.