About this role
Job Description
Summary:
Responsible for producing innovative bio-therapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment; maintaining areas in high state of inspection preparedness and utilizing business systems for inventory and process management. Maintain records to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Participate in the routine production of mammalian cell culture products within the Vacaville Manufacturing Facility, operating in at least one of the following production areas:
Upstream Manufacturing (UM): Primary focus is the cleaning, sterilization and operation of fixed vessel systems for media preparation, fermentation, and harvest operations; perform seed train operations; perform dispensing of components; handle and aliquot hazardous materials. Downstream Manufacturing (DM): Responsibilities include the operation and cleaning of fixed tank systems, the operation and cleaning of filtration systems, large-scale buffer preparation, and the operation of column chromatography systems; perform dispensing of components; hand