Scientist I/II, Downstream Process Characterization Direct Hire MA
Job ID: 16431 Direct Hire
Our growing Gene Therapy client in the Burlington, MA area is looking to bring on board a Scientist I/II, Purification Process Characterization to their Process Development group! This role will support the research and development of advanced purification methods and formulation development for AAV vectors. Role may also involve leading activities of associate scientists. Other responsibilities included but not limited to:
- Provide scientific leadership and define experimental strategy for late stage, BLA-enabling development and process characterization of cell culture systems for the production of high-quality vector products.
- Design and apply DOE studies to explore and establish acceptable operating ranges for all purification and vector production process parameters. Design and execute experiments and troubleshoot process and equipment when needed with associate scientists in the lab.
- Apply risk-based concepts to the characterization and scale-down model qualification of chromatography (affinity, ion exchange, size exclusion) and filtration processes including microfiltration, depth filtration, ultrafiltration, diafiltration, 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.
- Support process development leadership to ensure that internal development activities are aligned with external manufacturing milestones and timelines
- 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 Chemical Engineering, Biochemistry, Biology, Chemistry or a related discipline with 6+ years (BS/MS) or 3+ years (PhD) relevant downstream industry experience.
- Recent industrial experience with late-stage development and characterization of biologics or vaccine upstream process is highly preferred.
- Expertise with GE AKTA units, column chromatography, filtration and UF/DF (TFF) operations required. Experience with High Throughput Screening platforms such Tecan will be a plus.
- 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 with high-throughput process development and statistical design of experience (DoE) preferred.
- Experience with technology transfer to pilot plant or cGMP manufacturing for clinical stage products is preferred.