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 Executive Director, Analytical Development, the Associate Director, BioAnalytical Development will play a critical role in establishing a BioAnalytical group and ensuring analytical work is planned and executed consistent with supporting preclinical animal sample testing timelines for Neurogene’s product pipeline. The candidate will participate in activities related to assay development and execution to look for AAV products and potential efficacy biomarkers in samples from dose ranging studies, efficacy studies and toxicology studies performed in several animal species. 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 BioAnalytic assay and team development as well as day-to-day management of a BioAnalytical group.
Accountabilities and Responsibilities
• Establish and lead the BioAnalytical team to analyze preclinical samples
• Develop and qualify methods to isolate DNA from multiple tissue samples and tissue types using high throughput commercial instrumentation
• Develop and qualify methods for qPCR testing AAV DNA concentrations from multiple tissue samples and tissue types using high throughput commercial instrumentation
• Develop methods to test GOI expression (western blot format) from multiple tissue samples and tissue types using high throughput commercial instrumentation
• Develop ELISA’s and enzyme assays to detect proteins in preclinical samples
• Maintain electronic laboratory notebooks, present data to team, and write analytical test methods and study reports.
• Interact with quality assurance and preclinical 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.
• Expected to work with CROs to guide/manage external bioanalytical assay development and sample analysis including GLP studies
- Work Schedule
- Day shift
- Is knowledgeable and complies with all company safety policies, rules and regulations.
- Ensures all team members comply with safety policies, rules and regulations.
- PhD in Biochemistry, Cell Biology, or related field with 5-6 years of experience; or MS with 8-10 years of experience.
- Experience in a biotech industry environment is preferred. Exceptional BioAnalytical scientists with a deep academic background will be considered. Prior experience in a Core Lab setting is a plus.
- Working knowledge DNA extraction from animal tissues, qPCR and western blot assays as well as qualification/validation.
- Understanding of GLP principles, industry practices, and regulatory standards with ability to apply these to preclinical sample analytics.
- Ability to establish and lead a team of scientists and associates in analysis of preclinical samples.
- DNA isolation from preclinical samples, qPCR, western blot
- ELISAs, and enzymatic assay development from preclinical samples.
- 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.