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Senior Bioprocess Operations Specialist
2 months ago
About the Role:
We are seeking a skilled DSP Senior Bioprocess Scientist to join our team in Brisbane. This role offers an excellent opportunity to contribute to cutting-edge research and innovation in a collaborative and inclusive environment.
Responsibilities:
- Develop and execute DSP unit operations (chromatography, virus inactivation, virus filtration, ultrafiltration-diafiltration, and drug substance final fill) following strict production protocols and schedules in a clean room environment under cGMP conditions.
- Proactively identify and communicate practical problems to the responsible person.
- Maintain production suites, supplies, equipment, logbooks, and data, and close out batch records and material reconciliation per site SOPs and policies.
- Perform equipment maintenance and testing related to technical skills of a DSP Senior Bioprocess Scientist.
- Develop and implement new procedures and/or equipment in the OPS department in consultation with other owners and users.
- Author batch records, SOPs, and logbooks, and complete validation protocols.
- Implement Patheon cGMP Quality Management System and the Patheon EH&S requirements.
- Investigate minor and major deviations, propose and implement corrective and preventive actions, and ensure timely closure of deviation reports and change controls.
- Implement lean (OE) initiatives and continuous improvements.
- Transfer and understand specific new technologies to DSP.
- Collaborate with suppliers regarding technical issues.
Requirements:
- Tertiary education in a science or engineering field (e.g., bio-pharmaceuticals manufacture, biotechnology, process technology).
- Minimum of 1 year of industry work experience.
- Proven knowledge of cGMP environments.
- Specific knowledge of downstream processing such as chromatography protein purification, virus inactivation, virus filtration, ultrafiltration, and diafiltration, and formulation.
- Ability to work unsupervised with excellent communication, flexibility, reliability, and assertiveness.
About Us:
Thermo Fisher Scientific is a leading global organization in science, generating over $44 billion in annual revenue. Our mission is to support customers in creating a healthier, cleaner, and safer world. From accelerating life sciences research to solving analytical challenges, improving patient diagnostics and therapies, and enhancing laboratory efficiency, we provide comprehensive assistance.
We offer a comprehensive benefits package, including health and wellbeing benefits, flexible work arrangements, extra leave, charitable giving and volunteering opportunities, and learning and development programs.
Our values of Integrity, Intensity, Innovation, and Involvement guide our work and enable us to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.
