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Upstream/downstream Bioprocess Specialist

7 months ago

Brisbane, Australia Thermo Fisher Scientific Full time

**About us**:
**Position Summary**:
The Upstream/Downstream Bioprocess Specialist reports to the Operations Technical Support Manager of the Pharma Service Group (PSG) and the role is based in Brisbane.

**Key Responsibilities**:

- Works safely in accordance with EHS guidelines and adhere to Patheon cGMP Quality Management System requirements.
- Provide SME troubleshooting/oversight and support execution of the batch as needed to deliver the site key performance indicators of Right First Time and On Time Delivery.
- Builds partnerships and works collaboratively with the Operations Managers in mentoring Operations staffs with a focus on building talent depth and demonstrating positive behaviors as per 4i values.
- Support operational production and facility maintenance planning as well as the transfer of new technologies/procedures/equipment to Operations to address production demands as per S&OP and MPS.
- Review manufacturing batch records, standard operating procedures, logbooks, or validation protocols required for Phase III projects as per ICH guidelines.
- Assists Operations group with deviation investigation and determination/implementation of preventative/corrective actions.
- Ensure audit readiness within Operations by identifying and addressing gaps as well as preparing story boards and provide SME input during audit.
- Devises PPI initiatives to drive continuous improvement in Operations.

**Skills and Experience**:

- Must have at least 2+ yrs' cGMP experience and technical expertise in Cell Culture, Harvest Operations, or Downstream Processing.
- Have excellent written & verbal communication skills.
- Ability to work unsupervised, under pressure on multiple tasks and manage priorities independently.
- Possess strong organizational and planning skills and a commitment to excellence.
- Preferred to be educated to minimum Degree level in Biology, Chemistry or related field.
- Sufficient knowledge of Microsoft packages i.e. Word, Excel, PowerPoint, Microsoft Teams.
- Use of SFLMS, eDMS, Trackwise, SAP.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.