6701 Kaiser Drive Fremont, CA 94555 US
- Independently executes all routine unit operations in Purification including change-over procedures, scheduling within the shift team, equipment cleaning and set up.
- Able to perform in-process testing such as cell counting, spectrophotometry and environmental monitoring.
- Monitors and controls weights, flows, volumes, temperatures, pressure, and pH.
- Identify and report any issues related to manufacturing performance, process and safety to the team lead and assist in investigations of deviations in order to facilitate continuous process improvement.
- Train junior staff on unit operations such as bioreactors, cell separation, chromatography and tangential flow theory as well as CIP/SIP operations.
- All training will be conducted with an emphasis on safety and completion of operations in a timely manner.
- Collaborates within team and department in order to follow best practices and meet department goals.
- Report any issues related to manufacturing performance, process and safety to the manager in order to ensure safety, compliance with regulations and cGMPs and to facilitate continuous process improvement.
- Experience working with established GMP procedures and bulk manufacturing is a plus.
- Technical knowledge of manufacturing systems, methods and procedures.
- Understanding of purification/cell culture processes.
- Possess effective troubleshooting skills with equipment and/or process.
- Preferred, associates degree with (1) year closely related technical experience, preferably in a pharmaceutical or chemicals manufacturing environment