Manufacturing Associate II - Fermentation
Oakland-Fremont-Pleasanton Metro Area, CA
This manufacturing position will be responsible for the production/filling of approximately 25 commercial proteins in a regulated FDA licensed/ISO certified facility.
- Responsible for the ordering of required raw materials, reagents, & starting material in preparation for assigned production runs.
- Responsible for the thorough assembly, completion & review of run specific batch record packets.
- Perform SAP duties including cycle counting, reservations, charges to process orders & scrapping of expiring raw materials.
- Perform specific preventative maintenance related tasks as assigned, including column testing procedures on an annual basis & those associated with ongoing validation studies.
- Operate complex fermentation, synthesizer, filtration & centrifugation equipment.
- Perform all manufacturing operations under cGMP/ISO requirements
- Perform legible, clear & concise data entry into batch records, logbooks, & all other ancillary controlled forms used in a cGMP process.
- Responsible for analyzing in-process samples generated from protein purification processes.
- Complete all required documentation for proper traceability of a production lot.
- Operate a variety of basic lab equipment (pH meters, balances, centrifuges, & spectrophotometers) as well as more sophisticated equipment such as computers, HPLC systems, & densitometers
- 2 to 4 years of experience in a GMP environment
- BA/BS in the Sciences (Biology, Chemistry, or related field)