USP Bioprocess Scientist Level IV
Job ID :
Australia - Brisbane
- At least 4-5 years experience in USP including cell culture, single-use bioreactor (WAVE and SUB), single-use clarification, use of MFCS and cell banking in compliance with the relevant production protocols in a clean room environment under cGMP conditions.
- Experienced in troubleshooting of fed-batch, perfusion and clarification processes as well as equipment troubleshooting.
- Organised individual who is able to perform planning and scheduling as well as organising production suite, supplies, equipment and logbooks.
- Support and implementation of new procedures and/or equipment in the OPS department
- Review, revise and author manufacturing batch records, logbooks and material reconciliation.
- As the SME of USP unit operation and equipment, training co-workers that are unfamiliar with certain unit operation or handling of specific equipment, including approval of on-the-job trainings.
- Proposes and implements Corrective and Preventive Actions and support the on-time closure Deviation Reports and Change Controls
- Being the lead investigator for Minor and Major Deviation Reports.
- Pro-active in implementation of lean (OE) initiatives and continuous improvements under minimal direction.
- Adhere to Patheon cGMP Quality Management System and the Patheon EH&S requirements.