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Western Australia, Australia
Onsite
Work Schedule
12 hr shift/daysEnvironmental 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, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shiftJob Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Organise and execute downstream processing activities in accordance with approved protocols and production schedules
Operate independently in a cleanroom environment under cGMP conditions
Identify operational or technical issues, propose solutions, and communicate to relevant stakeholders
Maintain production suites, equipment, and supplies to ensure readiness
Complete and maintain logbooks and production data accurately
Perform batch record completion, review, and material reconciliation
Conduct equipment testing, troubleshooting, and technical assessments
Lead implementation of new procedures and equipment within the OPS department
Review, revise, and author batch records, SOPs, and logbooks
Execute validation protocols requiring advanced DSP expertise
Train co-workers on DSP processes and approve on-the-job training (OJT) completion
Act as Subject Matter Expert (SME) for DSP unit operations and/or equipment
Lead deviation investigations (minor and major), including root cause analysis
Develop, implement, and complete corrective and preventive actions (CAPA)
Ensure timely closure of deviation reports and change controls
Implement lean (Operational Excellence) initiatives with minimal supervision
Lead technology transfer activities and onboarding of new DSP processes
Liaise with suppliers/vendors to resolve technical issues
Ensure compliant, efficient, and independent execution of DSP manufacturing under cGMP conditions
Take ownership of planning, coordination, and execution of DSP activities
Maintain high standards of data integrity, documentation accuracy, and regulatory compliance
Provide technical leadership and act as SME for DSP processes and equipment
Lead training, coaching, and competency development of team members
Ensure equipment is maintained, reliable, and fit for purpose
Oversee and contribute to validation activities and protocol execution
Maintain and improve controlled documentation (batch records, SOPs, logbooks)
Lead and support quality systems including deviations, CAPA, and change control processes
Tertiary education in science or engineering-based field (i.e. biopharmaceuticals manufacture, biotechnology, process technology).
Experience working in cGMP environment and quality systems.
Specific knowledge of downstream processing such as chromatography protein purification, virus inactivation, virus filtration, ultrafiltration and diafiltration, and formulation.
Ability to work unsupervised
Strong organisational and planning skills
Good communication, flexibility, reliability and assertiveness
Responsible and proactive
The Patheon Biologics site (Part of Thermo Fisher Scientific) in Brisbane manufactures many products for clinical trials and commercial applications. This implies that the production activities range from implementing a totally new production run for the first time, to the routine production of a commercial batch. Due to the diversity of customers, and their associated products, the applicable processing steps are very diverse. Given the high value of the products and intermediates, the Bioprocess Scientist has to be capable of judging the possible impact of a situation on product quality, yield, EH&S and cGMP compliance. Due to involvement in the timely execution of manufacturing processes, a fair amount of discipline, organisational skills and flexibility in working hours are required.
Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.
Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
Flexibility: Balance your work and personal life with flexible arrangements.
Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.
Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you.
Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.
Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 125,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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.
