Clinical and preclinical stages of development for genomic medicines for serious diseases (gene & cell therapy & genome editing)
Greater San Francisco area
Manufacturing Lead, Upstream
Full-time, direct hire
The Manufacturing Lead will contribute to the manufacture of gene and cell therapies for clinical trials and future commercial scale. This individual will perform daily upstream and downstream manufacturing processes as well as act as on-the-floor lead during daily operations.
The Manufacturing Lead also perform manufacturing processes including but not limited to: cell culture thaw, cell culture maintenance and expansion, cryopreservation, transfection, purification using column chromatography, viral filtration, and TFF/UFDF.
This individual will be responsible for leading tech transfer activities into clinical manufacturing such as training with development staff, performing comparability studies, generating raw material specifications, coordinating and executing shakedown and/or engineering runs.
- Minimum of BS degree in a relevant, scientific field
- Minimum 3 years of experience in a GxP regulated lab environment
- Strong knowledge of biotech manufacturing processes such as cell thawing, cell expansion (shake flasks to production bioreactors), cell banking, inoculation and harvest is required
- Experience with upstream process equipment such as bioreactors (WAVE and XDR) and upstream analytical equipment such as cell culture analyzers is required
- Experience with upstream, downstream and/or cell therapy manufacturing operations is required
- Excellent aseptic technique
- Knowledge and/or experience with AAV and/or cell therapies a plus
- Experience with fill finish a plus
If you meet the requirements above and would like to be considered for this position, apply on-line now for immediate consideration and to be contacted with further details.