Growing Gene Therapy Company here in the Waltham, MA area is expanding and looking to add an Associate Director, Cell Culture Process Development to their team! This role will report into the Executive Director, Pharmaceutical Development and lead the R&D efforts of advanced cell culture and production methods AAV vectors. The incumbent will also lead the establishment of systems and business processesrequired to facilitate late-stage BLA-enabling development campaigns. Other responsibilities include but not limited to:
- Provide program-specific leadership and subject matter expertise for upstream process and development activities. Lead and mentor team members and direct laboratory activities to ensure that development milestones are aligned with program timelines.
- Establish sound business processes and systems to structure the development activities and information management in order to ensure the efficient delivery of a well-organized data package for IND- and BLA-enabling development.
- Provide hands-on leadership in the laboratory as needed, ensuring clear communication of experimental plans to ensure successful execution, leading analysis and documentation, requiring excellent writing skills and the flexibility to move between the management and execution as needed.
- Define and drive the process development strategy for the production of AAV vectors from mammalian cell culture by applying unit operations that are robust, scalable and suitable for cGMP production.
- Lead the team in efforts to apply engineering concepts to the screening, optimization and scale-up of mammalian cell culture system, incorporating advanced feeding strategies as necessary, as part of a comprehensive strategy to establish robust, scalable, and highly productive upstream processes and ensure technical success in manufacturing campaigns.
- Generate, manage, evaluate, and maintain critical data in a highly organized manner. Author technical reports, tech transfer documents, and prepare scientific presentations as needed. Write/revise SOPs as needed.
- Apply cutting edge technologies in bioprocessing to AAV manufacturing, independently formulate new technology development initiatives and carry them to patent and public disclosure
- Collaborate within a cross-functional department (Process Development, Analytical Development, Quality, and Manufacturing) to establish robust cross-functional planning to further advance the science.
- BS, MS or PhD in Biochemical Engineering, Biotechnology, Biochemistry or a related discipline AND 12+ years (BS/MS) or 8+ years (PhD) relevant industrialexperience in bioprocessing.
- Demonstrated thought leader in the development and scale-up of mammalian cell culture processes for the production of biologics, biotechnology products, vaccines, or viral vector products for clinical or commercial disposition.
- Recent experience with late-stage development of biologics or viral vector products, with familiarity in establishing a risk-based approach to BLA-enabling studies.
- An in-depth understanding of engineering methodology required for implementing and scaling-up advanced feeding strategies of mammalian cell culture systems for the production of live viral vectors or vaccines, or large molecule biologics.
- High level understanding of complex analytical methods used to support process development of viral vector products is required.
- Experience in working with and managing outside vendors.