Responsibilities include, but are not limited to:Perform all tasks associated with the manufacture of clinical product following batch records and SOPs. Work as part of a small team to execute GMP runs in close collaboration with Process Development and Quality. Assist in the development of standard operating procedures, batch records, deviations and change controls. Successfully troubleshoot processing and equipment issues. Other duties as assigned.
Requirements: Requires Bachelor�s degree and/or advanced degree or 3 or more years of cGMP experience in a manufacturing pharmaceutical/biotechnology environment. Cell culture processing experience. Previous experience with cell therapy products is a plus. Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture products. Strict adherence to SOPs and cGMP regulations, the ability to accurately complete documentation associated with clinical manufacturing. Excellent aseptic/sterile techniques and prior experience with cell culture, cell culture equipment including Wave bioreactors. Experience with handling and propagation of human primary cells, including T cells. Excellent skill in Microsoft word, Excel and data analysis. Ability to think critically, and demonstrated troubleshooting and problem solving skills. Self-motivated and willing to accept temporary responsibilities outside of initial job description. Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment. Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities. Ability to work off-shift and extra hours as required
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