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 to the Executive Director, Product Development and Operations, the Senior Downstream Process Development Scientist plays a critical role in ensuring downstream process development work is planned and executed consistent with timelines for Neurogene’s product pipeline. The candidate will manage all work activities related to downstream process development and technology from academic collaborators and to the manufacturing team and/or selected contractors and CDMOs. This hands-on technical leadership role in a rapidly-growing start-up will be accountable for target process profile definition, process design and execution of all purification activities, including chromatography, UF/DF, centrifugation, product formulation, process scale-up and optimization activities, and all purification-related technical documentation. The successful candidate will be able to design, characterize tech transfer and optimize a robust, scalable, productive downstream process for the generation of therapeutic AAV products in the pipeline. The selected candidate will have a demonstrated track record of successfully advancing AAV products from discovery to clinical stages, along with superior written/oral communication skills. Furthermore, independence and self-motivation, ability to anticipate challenges in scale-up to commercially viable volumes will characterize the ideal candidate.
Accountabilities and Responsibilities
- Design, develop and implement scalable, GMP-suitable harvest and purification unit operations preferentially in single-use systems including affinity chromatography, membrane, monolith or resin-based AEX, hollow fiber and UF/DF able to clear product from process related impurities, while maintaining high yield overall process yield and intact product potency.
- Identify and advance the understanding of critical process parameters for the continuous optimization and robust manufacture of AAV pipeline products.
- Able to identify, assess and implement industry-leading trends to ensure maximum process efficiencies
- Responsible for the successful tech transfer of the developed downstream process to the manufacturing team.
- Accountable for the planning, resourcing, and management of all downstream development needs, in collaboration with the manager.
- Serve as a subject matter expert to interact with key stakeholders to support company growth and to evaluate new downstream process requirements and trends as needed. Effectively communicate direction and progress.
- Collaborate closely with analytical development and upstream development functions to identify critical quality attributes and process performance parameters for AAV purification. Evaluate and trend in-process and analytical data.
- Author technical reports, tech transfer documents, supporting technical sections of IND submission, as needed.
- 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
- Stay current and connected in the rapidly-growing field of viral vector process development, and attend several outside meetings/conferences yearly, presenting whenever possible.
- Work Schedule
- Day shift
- Less than 10%
- Safety & Quality
- Knowledgeable and complies with all company safety policies, rules and regulations.
- Ensures Downstream team members comply with safety rules and regulations.
- Leadership Responsibility
- Able to lead 1-3 Scientist/Associate Scientists
- MS or Ph.D. in (Bio)Chemical engineering, Cell Biology, Virology or related field.
- At least 5 years (with MS) and 3 years (with Ph.D.) of related experience preferably in a biotech environment. Knowledge of statistical process control will characterize the exceptional candidate
- Working knowledge of global cGMPs related to all aspects of biologics manufacturing, including FDA/EMA regulations related to cell/gene therapy and aseptic manufacturing of drug products. Prior experience with GMP documentation including batch records, deviations is a plus.
- Understanding of gene therapy principles, industry practices, and regulatory standards with the ability to apply these to GMP analytics.
- Experience in tech transfer and scale-up using chromatography skids, UF/DF, and formulation development to high concentrations, and purification through pilot-scale required.
- Solid understanding of and experience with in-process and final product analytics for product quality monitoring is a must.
- Demonstrated strong aptitude 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 with the ability to adapt to changing priorities. 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 practices.
- Working Conditions
- Majority of the work is performed in Laboratory conditions