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!
Want more jobs like this?
Get Science and Engineering jobs in Brisbane, Australia delivered to your inbox every week.
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.