- Fully trained and independently complete 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 . Support and implement new procedures and/or equipment in the OPS department in consultation with other owners and users.
- Revise and author batch records, SOPs and logbooks.
- Complete validation protocols for which a DSP Bioprocess Scientist skill is required.
- Adhere to Patheon cGMP Quality Management System and the Patheon EH&S requirements.
- Being the lead investigator for minor and major deviation, and propose and implement corrective and preventive actions, as well as ensure 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.
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DSP Senior Bioprocess Scientist - Brisbane, Australia - Thermo Fisher Scientific
Description
:Minimum Requirements/Qualifications:
Qualifications & Experience
Tertiary education in science or engineering based field ( biopharmaceuticals manufacture, biotechnology, process technology). Very good knowledge in cGMP environment. Specific knowledge of downstream processing such as chromatography protein purification, virus inactivation, virus filtration, ultrafiltration and diafiltration, and formulation.
Skills & Attributes
Ability 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.
