Director of Process Development and CMC Strategy
13 hours ago
Director of Process Development and CMC Strategy
Job Summary:SystImmune Inc. is seeking a highly experienced Director of Process Development and CMC Strategy to lead the development of small molecule processes. The successful candidate will have a strong background in CMC strategy, small molecule drug development, and process development.
Key Responsibilities:- Provide technical leadership in process development of small molecules, overseeing strategic and day-to-day activities.
- Lead and guide process characterization, validation studies, and technology transfer initiatives for small molecule therapeutics.
- Collaborate with the manufacturing facility and R&D center in Chengdu, China, to ensure alignment in process development, scale-up, and manufacturing activities.
- Develop and implement analytical strategies to support antibody and ADC development.
- Compile and review CMC sections for IND, BLA, and other regulatory submissions.
- Ph.D. in chemistry, pharmaceutical sciences, or a related field with at least 10+ years of laboratory experience in an industrial setting.
- M.S. in a relevant field with at least 12+ years of laboratory experience in an industrial setting.
- Extensive experience in CMC strategy and small molecule drug development.
- Deep understanding of the design, development, optimization, and tech transfer of small molecule drug substance manufacturing processes.
- Expertise in developing, optimizing, troubleshooting, and tech transferring analytical methods for small molecules.
SystImmune offers a comprehensive benefits package, including 100% paid employee premiums for medical/dental/vision, STD, LTD, a 401(k) plan with a 50% company match of up to 3%, and a vesting schedule of only 5 years.
About SystImmune:SystImmune is a stable, well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
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