USP Bioprocess Scientist

Job Description
Job Title: Bioprocess Scientist, USP
Reports to: USP Team Lead
Group / Division: Pharma Service Group (PSG)
Position Location: Brisbane, Australia
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:
Perform processes in a clean room environment under cGMP conditions.
Contribute to Department functions, such as maintaining production suite, supplies, equipment, logbooks, and data in accordance with site SOPs and policies.
Deliver sustained improvement in the site key performance indicators of Right the First Time and On Time Delivery.
Adhere to Patheon Biologics cGMP Quality Management System and the EH&S requirements.
Perform equipment testing, troubleshooting and validation. Support and implement new procedures and/or equipment in the OPS department in consultation with other owners and users.
Assist with batch record close-out, deviation reports, Corrective and Preventative Actions (CAPAs) and change controls.
Assist in the completion and identification of lean initiatives and continuous improvements.
Connect 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 and on-call. Should this be a requirement of your position, you will be remunerated per the Company’s policy.
A pro-active attitude and personal initiative is expected to identify and overcome practical problems, propose possible solutions and communicate to the responsible person/s.
Frequent Contacts:
Internal
QA, QC, USP, DSP, MBP, Tech Transfer, VAL, ENG, EH&S and WHS
Externals
External Auditors and Customers
Minimum Requirements/Qualifications
Qualification and Experience:
Preferably a tertiary education in science or engineering based field (i.e. biopharmaceuticals manufacture, biotechnology, process technology).
1+ years of proven experience in the bio (pharmaceutical) fields or similar.
Good knowledge and working in cGMP environment is highly preferred.
Skills and 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.
Excellent oral and written communication skills, as well as interpersonal skills.
Proven track record to thrive in a fast-paced and dynamic environment.
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.
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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.