Associate Director, Upstream Process Development

Our Gene Therapy client based in Bedford, MA is looking to add an AD/Director, Upstream Process Development to their team!  This role will lead a group of scientists and associate scientists responsible for the development of viral vector cell culture processes, technology transfer to manufacturing sites, overseeing process scale up operations, defining scale down models, and authoring of associated regulatory filing documents. We are looking for a candidate with excellent scientific, communication, and project management skills.

  • Lead a group of scientists and associate scientists responsible for successful viral vector process development, process characterization, execution of upstream processes, and technology transfer to manufacturing sites.
  • Oversee the process development and scale-up operations, defining scale down models.
  • Drive innovation to enhance viral vector productivity and quality.
  • Make strong technical, strategic contributions to cross functional development project teams.
  • Manage a multi project development portfolio.
  • Author associated regulatory filing documents.
  • Present findings and/or results to senior management, external stakeholders, and industry leaders at national/international conferences.
  • Build upstream department timeline and budget.
     

Requirements:

  • PhD degree in Biotechnology, Cell Biology, Biochemistry, Chemical Engineering or related discipline with a minimum of 6 years of relevant experience or a Bachelor’s degree with a minimum of 14 years of experience.
  • Experience in executing projects to aggressive timelines with the ability to adapt to rapid changes in project priorities.
  • Experience in the biotech/pharmaceutical industry within a cell culture role and an excellent understanding of the theory and practice of cell culture process development is required.
  • Molecular understanding of viral vector productions, in particular AAV biology, is highly desired.
  • Strong cell culture expertise and knowledge pertaining to AAV production.
  • Minimum of 3 years of experience managing direct reports or project teams.

Preferred Qualifications:

  • Experience in the development of Sf9-baculovirus based AAV production.
  • Experience in cell line generation and media development.
  • Experience in scale up and scale down of bioreactor processes.
  • Fluent in speaking, reading and writing Chinese.