Job ID: 15772 Direct Hire MA
Mid-Size Gene Therapy company in the Waltham, MA area is expanding! They are looking to bring on board Sr. Research Associate, Cell Culture Process Development! This role will conduct experiments aimed at defining robust bioreactor processes for the production of gene therapy products in HEK293 cells or an alternative production platform that is robust, scalable and suitable for cGMP production. Responsibilities include but not limited to:
- Apply engineering concepts to develop and 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.
- Conduct well-designed experiments and troubleshoot process and equipment when needed with associate scientists in the lab.
- Contribute to development programs to enhance manufacturing technologies, capabilities and processes (such as media development, bioreactor fed-batch and perfusion process development, optimization and scale-up).
- 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.
- Must demonstrate a keen knowledge of experimental design, underlying scientific principles, and the ability to analyze and assess results.
- BS in Biochemical engineering or Biological Sciences with 4+ years, or MS with 2+ 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 viral vectors, live viral vaccines, 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.
- Ability to execute and follow-through to completion and documentation.