USP Bioprocess Scientist III
3 weeks ago
Job Description
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
When you're part of the team at Thermo Fisher Scientific, you'll do important work. Surrounded by collaborative colleagues, you'll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.
Position Summary:
Manufacturing of biopharmaceutical products in compliance with international quality requirements as defined by TGA, FDA, EMEA, ICH etc. If this sounds like you, we'd love to hear from you
Key Responsibilities:
- Manufacturing of biopharmaceutical products in compliance with international quality requirements as defined by TGA, FDA, EMEA, ICH etc. If this sounds like you, we'd love to hear from you
- Key Responsibilities:Independently operate USP unit operations and equipment (Single Use Bioreactors and associated control software, shake flask, Wave Bioreactors, clarification processes etc) within a GMP environment.
- Independently organise several unit operations in accordance with the applicable production protocols and planning schedules, in a clean room environment under cGMP conditions.
- Perform equipment testing and equipment troubleshooting related to technical skills of Bioprocess Scientist III.
- Review, revise and author manufacturing batch records and material reconciliation.
- Write and carry out validation protocols for which a Bioprocess Scientist technical skill is required.
- Adhere to Patheon Biologics cGMP Quality Management System and the EH&S requirements.
- As SME of a number of unit operation or equipment, train co-workers that are unfamiliar with the certain unit operation or handling of specific equipment, including approval of on-the-job training.
- Lead deviation investigations and change controls to streamline and improve internal processes.
- Propose and implement Corrective and Preventive Actions and support the closure of Deviation Reports and Change Controls as well as writing Minor Deviation Reports in a timely manner.
- Lead lean (OE) initiatives and continuous improvements.
- Identify and overcome practical problems, proposes a possible solution and communicates to the responsible person.
- Support Department functions, such as maintaining production suite, supplies, equipment, logbooks, and data in compliance with site SOPs and policies.
- Support the transfer and understanding of specific new technologies to the Operations department.
- Support and implementation of new procedures and/or equipment in the OPS department in consultation with other owners and users.
- Assist in review and writes quality GMP documentation.
- Liaise with suppliers about issues of technical nature.
- Any reasonable additional tasks that might be required for day to day Operational activities.
- This role may require you to be on shift, on-call roster and work some scheduled weekends. Should this be a requirement of your position, you will be remunerated per the Company's policy
Minimum Requirements/Qualifications:
Qualifications & Experience:
Preferably tertiary education in science or engineering based field (i.e. biopharmaceuticals manufacture, biotechnology, process technology).
Skills & Attributes:
USP – cell culture passaging, WAVE bioreactors, 50 L – 2000 L stirred tank bioreactors for fed-batch and perfusion process, cell banking and depth filtration.
Proven track record to thrive in a fast-paced and dynamic working environment.
Excellent oral and written communication skills, as well as interpersonal skills.
Other Important Information
The Thermo Fisher Scientific site in Brisbane manufactures many products for clinical trials and commercial applications. 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, interpersonal and organisational skills and flexibility in working hours are required.
Other Job Requirements:
Adhere to EH&S processes and ensure a safe and healthy workplace environment. Work safely and only perform tasks if currently competent and / or authorized. Report hazardous conditions, hazardous actions, incidents and near-miss incidents. Participate in EH&S activities (such as inspections and risk assessments) as advised.
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 100,000+ 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.
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.
-
Senior Bioprocess Scientist USP
5 days ago
Brisbane, Queensland, Australia Thermo Fisher Scientific Full timeJob DescriptionWhen you're part of the team at Thermo Fisher Scientific, you'll do important work. You'll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make...
-
Senior Bioprocess Scientist USP
3 weeks ago
Brisbane, Queensland, Australia ThermoFisher Scientific Full timeJob Description When you're part of the team at Thermo Fisher Scientific, you'll do important work. You'll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make...
-
Senior Bioprocess Scientist USP
6 days ago
Brisbane, Queensland, Australia ThermoFisher Scientific Full timeJob Description When you're part of the team at Thermo Fisher Scientific, you'll do important work. You'll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make...
-
Senior Bioprocess Scientist USP
3 weeks ago
Brisbane, Queensland, Australia ThermoFisher Scientific Full timeJob Description When you're part of the team at Thermo Fisher Scientific, you'll do important work. You'll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make...
-
Bioprocessing Scientist
6 days ago
Brisbane, Queensland, Australia KE Select Full timeThe Company Our client is a world leader in supporting science and has a state-of-the-art facility in Brisbane that specializes in clinical and commercial manufacturing and single-use biologics technology. The Brisbane site boasts expertise in GMP for clinical and commercial manufacturing and is in a period of growth and expansion. The RoleAn exciting...
-
Senior Bioprocess Scientist DSP
6 days ago
Brisbane, Queensland, Australia Thermo Fisher Scientific Full time: Fully trained and independently complete DSP unit operations with the applicable production protocols and planning schedules, in a clean room environment under cGMP conditions. Identify and communicate practical problems to the responsible person, demonstrating a proactive attitude and personal initiative. Contribute to DSP functions, such as...
-
Senior Bioprocess Scientist DSP
6 days ago
Brisbane, Queensland, Australia Thermo Fisher Scientific Full timeWork ScheduleOtherEnvironmental ConditionsAdherence 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 -22degrees, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required...
-
Bioprocess Technician
5 days ago
Brisbane, Queensland, Australia KE Select Full timeOur client is a world leader in supporting science and has a state-of-the-art facility in Brisbane that specializes in clinical and commercial manufacturing and single-use biologics technology. The Brisbane site boasts expertise in GMP for clinical and commercial manufacturing and is in a period of growth and expansion. An exciting opportunity for a...
-
Usp Supervisor
5 days ago
Brisbane, Queensland, Australia Thermo Fisher Scientific Full timeAbout usThe Upstream (USP) team within Operations at Brisbane site carries out manufacturing of biopharmaceutical products in compliance with international quality requirements as defined by TGA, FDA, EMEA, ICH and other regulatory bodies. We're looking for a USP Supervisor to join the existing team in Brisbane. If this sounds like you, we'd love to hear...
-
Usp Supervisor
5 days ago
Brisbane, Queensland, Australia Thermo Fisher Scientific Full timeAbout us:Position Summary:The Upstream (USP) team within Operations at Brisbane site carries out manufacturing of biopharmaceutical products in compliance with international quality requirements as defined by TGA, FDA, EMEA, ICH and other regulatory bodies. We're looking for a USP Supervisor to join the existing team in Brisbane. If this sounds like you,...
-
USP Supervisor
5 days ago
Brisbane, Queensland, Australia Thermo Fisher Scientific Full timeJob DescriptionAbout usThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the world Healthier, cleaner and Safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and...
-
USP Supervisor
6 days ago
Brisbane, Queensland, Australia ThermoFisher Scientific Full timeJob Description About usThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the world Healthier, cleaner and Safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and...
-
USP Supervisor
2 weeks ago
Brisbane, Queensland, Australia ThermoFisher Scientific Full timeJob Description About usThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the world Healthier, cleaner and Safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and...
-
Production Supervisor
6 days ago
Brisbane, Queensland, Australia KE Select Full timeOur client is a global leader in providing support to the scientific community. They have a cutting-edge facility located in Brisbane that specializes in clinical and commercial manufacturing as well as single-use biologics technology. The facility adheres to Good Manufacturing Practices (GMP) for clinical and commercial manufacturing. About the role:An...
-
Upstream/downstream Bioprocess Specialist
5 days ago
Brisbane, Queensland, Australia Thermo Fisher Scientific Full timeAbout usThe 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...
-
Upstream/Downstream Bioprocess Specialist
5 days ago
Brisbane, Queensland, Australia ThermoFisher Scientific Full timeJob DescriptionAbout usThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the world Healthier, cleaner and Safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and...
-
Upstream/Downstream Bioprocess Specialist
3 weeks ago
Brisbane, Queensland, Australia ThermoFisher Scientific Full timeJob DescriptionAbout usThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the world Healthier, cleaner and Safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and...
-
Upstream/Downstream Bioprocess Specialist
3 weeks ago
Brisbane, Queensland, Australia ThermoFisher Scientific Full timeJob DescriptionAbout usThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the world Healthier, cleaner and Safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and...
-
Upstream/Downstream Bioprocess Specialist
6 days ago
Brisbane, Queensland, Australia Thermo Fisher Scientific Full time: Works safely in accordance with EHS guidelines and adhere to Patheon cGMP Quality Management System requirements. Becomes subject matter expert (SME), remains trained and qualified in area of expertise, and displays initiative in personal development opportunities to further enhance skills and expertise relevant to the position. Provide SME...
-
QA Officer
5 days ago
Brisbane, Queensland, Australia Thermo Fisher Scientific Full timeAt Thermo Fisher Scientific, each one of our 100,000+ extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.As an employee at Thermo Fisher Scientific, you'll do important work. Surrounded by collaborative colleagues, you'll have the support and...
