Head of Downstream Process Development Direct Hire MA
Job ID: 16066 Direct Hire MA
Growing Gene Therapy Company here in the Waltham, MA area is expanding and looking to add an Head of Downstream Process Development to their team! This role will report into the Executive Director, Pharmaceutical Development and lead the R&D efforts of advanced purification methods and formulation development for AAV vectors. The incumbent will also lead the establishment of systems and business processes required to facilitate late-stage BLA-enabling development campaigns. Other responsibilities include but not limited to:
- Provide leadership and subject matter expertise for all downstream process and formulation development activities. Lead and mentor downstream 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 purification of AAV vectors from mammalian cell culture by applying unit operations that are robust, scalable and suitable for cGMP production.
- Apply engineering concepts to the screening, optimization and scale-up of chromatography (affinity, ion exchange, size exclusion) and filtration processes including microfiltration, depth filtration, ultrafiltration, and sterile filtration.
- 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 7+ years (PhD) relevant industrial experience in bioprocessing.
- Expertise with GE AKTA units, column chromatography, filtration and UF/DF (TFF) operations required to develop and manufacture high quality biologics, biotechnology, vaccine, 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 purification of viral vectors, live viral vaccines, or large molecule biologics, including process scale-up and tech transfer.
- Understanding of analytical methods used to support biologics purification process development is needed.
- Experience in working with and managing outside vendors.