USP Bioprocess Scientist II
On-siteBrisbane, Queensland, Australia
Job Summary
Execute USP unit operations including cell culture passaging, bioreactor management, and depth filtration under cGMP conditions. Maintain production suites, equipment, and logbooks while closing batch records and conducting material reconciliation. Author SOPs, implement lean initiatives, and support deviation investigations and change controls. Perform equipment maintenance, test new technologies, and collaborate with suppliers on technical issues. Complete corrective and preventive actions to ensure timely closure of reports. Work 12-hour shifts in a cleanroom environment handling hazardous materials, adhering to strict safety standards and PPE requirements.
Required Qualifications
- 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
- Fluctuating Temps hot/cold
- 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
- Working at heights
- 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)
- Applicable production protocols and planning schedules
- Clean room environment under cGMP conditions
- Pro-active attitude and personal initiative
- Maintaining production suite, supplies, equipment, logbooks, and data
- Closing out batch record and material reconciliation in accordance with site SOPs and policies
- Perform equipment maintenance and testing related to technical skills of Bioprocess Scientist USP
- Support and implement new procedures and/or equipment in the OPS department
- Revise and author SOPs and logbooks
- Adhere to Patheon cGMP Quality Management System and the Patheon EH&S requirements
- Complete corrective and preventive actions
- Contribute in deviation investigations
- Support the timely closure of deviation reports and change controls
- Implement lean (OE) initiatives and continuous improvements
- Contribute to the transfer and understanding of specific new technologies to USP
- Connect with supplier about issued of technical nature
- Either experience in pharmaceutical industry OR tertiary education in science or engineering-based field (i.e. biopharmaceuticals manufacture, biotechnology, process technology)
- Good understanding of cGMP practices
- Ability to work unsupervised
- Good communication
- Flexible
- Reliable and assertive
- Responsible and proactive
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