Job DescriptionAt Thermo Fisher Scientific, each one of our 75,000 outstanding 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!Becoming 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. Our respected, growing organization has an outstanding strategy for the near term and beyond. Join our strong team, and help us make significant contributions to the world!Job Title:
Bioprocess Scientist II DSPReports to: DSP SupervisorGroup / Division: Pharma Service Group (PSG)Career Band: Band 3Job Family: OperationsJob Sub Family: Manufacturing – Formulation (MFGF)Job Code: OPS.MFGF.A03Job Track: ProfessionalPosition Location: Brisbane, AustraliaNumber of Direct Reports: 0
Position Summary:Manufacturing of biopharmaceutical products in compliance with international quality requirements as defined by TGA, FDA, EMEA, ICH, etc.
Key Responsibilities:- Trained on and support execution of DSP unit operations (chromatography, virus inactivation, virus filtration, ultrafiltration-diafiltration and drug substance final fill) with the applicable production protocols and planning schedules, in a clean room environment under cGMP conditions.
- A pro-active attitude and personal initiative is encouraged to identify practical problems and communicates to the responsible person.
- Contribute in their DSP functions, such as maintaining production suite, supplies, equipment, logbooks, and data, as well as closing out batch record and material reconciliation in accordance with site SOPs and policies.
- Perform equipment maintenance and testing related to technical skills of Bioprocess Scientist DSP. Support and implement new procedures and/or equipment in the OPS department in consultation with other owners and users.
- Revise and author SOPs and logbooks.
- Adhere to Patheon cGMP Quality Management System and the Patheon EH&S requirements.
- Complete corrective and preventive actions, contribute in deviation investigations and support the timely closure of deviation reports and change controls.
- Implement lean (OE) initiatives and continuous improvements.
- Contribute to the transfer and understanding of specific new technologies to DSP.
- Connect with supplier about issued of technical nature.
Frequent Contacts:Internal: QA, QC, USP, DSP, MBP, PE, VAL, ENG, EH&S and WHSExternal: N/A
Minimum Requirements/Qualifications:Qualifications & Experience- Either experience in pharmaceutical industry OR tertiary education in science or engineering-based field (i.e. biopharmaceuticals manufacture, biotechnology, process technology).
- Good understanding of cGMP practices.
Skills & AttributesAbility to work unsupervised. Good communication, flexibility, reliability and assertiveness. Responsible and proactive.
Other Important Information: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.
Other Job Requirements:Adhere to EH&S policies and procedures and ensure a safe and healthy workplace environment. Work safely and only perform tasks if currently proficient and / or authorised. Report hazardous conditions, hazardous actions, incidents and near-miss incidents. Participate in EH&S activities (such as inspections and risk assessments) as advised.Your position may require you to be on shift or on call. Should this be a requirement, there will be remuneration as per the Company’s policy.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.
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