Senior Scientist, Viral Based Gene Therapeutic Process Development
MilliporeSigma is seeking a highly motivated and creative individual to be a part of a cutting-edge gene therapy process development team for the Carlsbad Viral Vector Manufacturing facility. The candidate will support the development of unit operations for viral vector production utilizing best practices to optimize viral yields across multiple viral types. You will also provide input for areas of innovation, new product development, and technical representation to advance MilliporeSigma as the leader in contract viral vector manufacturing.
- Primary lead and scientific resource for a wide variety of internal and client-driven projects to develop cGMP compatible viral vector production processes.
- Responsible for understanding the scope of work, generating all related documentation, executing the studies, developing and executing analytical assays, analyzing results, and writing development reports.
- Interface with clients prior to initiating programs to provide technical guidance, as well as throughout the project to provide updates and troubleshooting when needed.
- Support technical process transfers internally and from 3rd party sites.
- Serve as technical subject matter expert with Business Development and Contracting to generate the scope of work for new projects as well as provide projected costing.
- Work cross-functionally with the Tech Transfer and Manufacturing teams to facilitate the transfer of the processes from Process Development into GMP Manufacturing.
- Support Process Characterization and Process Validation studies.
- Provide technical support during client and regulatory agency site audits as needed.
- Communicate effectively with Technical Operations Leadership team, internal and external network partners and the Product Teams.
Who you are:
- Bachelor of Science in Biology, Biochemistry, Chemistry, Chemical Engineering, or other Life Sciences with 15+ years of Biotech, Pharma, Medical Device or Manufacturing work experience
- Master’s Degree in Biology, Biochemistry, Chemistry, Chemical Engineering, or other Life Sciences with 10+ years of Biotech, Pharma, Medical Device or Manufacturing work experience
- PhD in Biology, Biochemistry, Chemistry, Chemical Engineering, or other Life Sciences with 7+ years of Biotech, Pharma, Medical Device or Manufacturing work experience
- 7+ years hands-on experience in Upstream OR Downstream Bioprocessing unit operations and development of analytical assays
- 7+ years in cGMP manufacturing and Quality Systems within an FDA regulated environment
- Experience with viral vector production at the research and pilot scale, mammalian cell culture processes (adherent and in bioreactors), and single-use systems
- Analytical assay experience (ddPCR, ELISA, FACS, HPLC, SDS PAGE)
- Experience with downstream unit operations (clarification, tangential flow filtration, and chromatography)
- Ability to exercise significant judgment when analyzing complex projects and demonstrate a high level of scientific achievement and understanding
- Experience with JMP or similar software for experimental design and analysis
- Innovative approach to problem-solving and integrated view of business/scientific issues
- Ability to promote a culture of continuous improvement within Process Development; act as champion on initiatives and/or projects to drive improvement in client service
- Ability to lead by example, offer scientific coaching and mentoring to other staff members (training and scientific support for ongoing projects)