Backed by 500 Global.
About the role
The Associate Director, Drug Substance MSAT, leads end-to-end process stewardship (Upstream and Downstream) for an assigned manufacturing suite (DSM1 or DSM2). The role executes MSAT strategy, builds and develops a team of scientists and engineers, and optimizes large scale cell culture operations across seed/production bioreactors and purification trains. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Master’s degree in an Engineering or Scientific field with 9+ years of experience OR Bachelor’s degree in an Engineering or Scientific field with 11+ years of experience
- 8+ years of people management/leadership experience
- 9+ years of CMC experience leading pre-approval and post-approval activities for biologic product, including process development and Good Manufacturing Practices (GMP)
More about this role
The Associate Director, Drug Substance MSAT, leads end-to-end process stewardship (Upstream and Downstream) for an assigned manufacturing suite (DSM1 or DSM2). The role executes MSAT strategy, builds and develops a team of scientists and engineers, and optimizes large scale cell culture operations across seed/production bioreactors and purification trains. With a focus on innovation and reliability, this leader drives technical stewardship through tech transfer execution, process performance qualification (PPQ) execution, commercialization, as well as continuous improvement initiatives. This leader partners closely with the rest of the MSAT leadership team, Manufacturing, QA, Automation, and Engineering to improve systems and working methods. The Associate Director serves as the suite’s technical owner in client forums, translating product requirement needs into clear plans, stage gates, and flawless execution to enable compliant, on time Drug Substance delivery.
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug...
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