Scientist I/II, Upstream Process Development Direct Hire MA
Job ID: 16355 Direct Hire MA
Our large Gene Therapy client is going and looking to add a Scientist I/II to their Upstream Process Development team! This role will focus on late-stage upstream process development efforts. Will lead the design and execution of experimental strategies aimed at defining robust bioreactor processes for the production of AAV vectors in HEK293 cells or an alternative production platform that is robust, scalable and suitable for cGMP production. Other responsibilities include but not limited to:
- Provide scientific leadership and define experimental strategy for addressing clinical development program objectives for the development and optimization of cell culture systems for the production of high quality AAV vector products.
- Apply engineering concepts to develop and rationally scale the mammalian cell culture processes, including transient transfection, clarification of harvested material, and other upstream unit operations.
- Design and apply DOE studies to develop, refine, optimize and characterize cell culture and vector production processes. Design and execute experiments and troubleshoot process and equipment when needed with associate scientists in the lab.
- Lead/Conduct laboratory studies to enhance AAV manufacturing technologies, capabilities and processes (such as media development, bioreactor fed-batch and perfusion process development, optimization and scale-up).
- Mentor associate scientists to 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.
- Must demonstrate a keen knowledge of experimental design, underlying scientific principles, and the ability to analyze and assess results.
- PhD in Biochemical engineering, Virology, Biochemistry, or Biological Sciences with applicable academic or industrial experience in mammalian cell culture process development, or MS with 6+ year of industrial experience in mammalian cell culture process development.
- Experience with small or large scale single-use bioreactor operations, and technology transfer to pilot plant or cGMP manufacturing for clinical stage products is preferred.
- Familiarity with development of producer cell lines, high throughput or disposable bioreactors, culture media development, or perfusion unit operations is preferred.
- Should be highly motivated, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities.