USP Bioprocess Scientist II

Job description

Work Schedule 12 hr shift/days Environmental Conditions: Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Warehouse, Will work with hazardous/toxic materials Job Description: Position Summary: Manufacturing of biopharmaceutical products in compliance with international quality requirements as defined by TGA, FDA, EMEA, ICH, etc. Key Responsibilities: - Trained on and support execution of USP unit operations (cell culture passaging, WAVE bioreactors, 50 L – 2000 L stirred tank bioreactors for fed-batch and perfusion process, cell banking and depth filtration) with the applicable production protocols and planning schedules, in a clean room environment under cGMP conditions. - A...