GeneFab
GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies.
Cell Therapy • Gene Therapy • Synthetic Biology
11 - 50
Senior Research Associate II (SRA II), Cell Therapy Process Development
August 27
🏢 In-office - Bay Area
GeneFab
GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies.
Cell Therapy • Gene Therapy • Synthetic Biology
11 - 50
Description
• Translate scientific understanding to development of cGMP cell therapy manufacturing unit operations (i.e. activation, expansion, gene editing (viral/non-viral), cryopreservation) • Support designing and executing experimental studies for new manufacturing technologies • Apply QbD principles to improve process performance and manufacturability • Collect, interpret, and present technical experimentation results to project teams • Author (e.g. study protocols, technical reports, ELNs) or support authoring (e.g. sampling plans, batch records, specifications) of key documentation to enable technology transfer • Build and maintain strong and credible interactions with internal stakeholders • Support delivery of phase-appropriate technology transfer strategies • Serve as a technical resource and guide for evaluation of root cause analyses and continuous improvement initiatives • Management of sample submissions, inventories, and raw materials testing/acquisition • Flexible support of other C> laboratory operations as needed
Requirements
• BS/MS Degree in science/engineering with 4-6+ years of experience in laboratory setting (preferably cell therapy development/manufacturing) • Experience with participating in lab focused process development and technology transfer activities • Strong technical writing and communication skills to support both development and tech transfer applications
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