DSP Senior Bioprocess Scientist

at  Thermo Fisher Scientific

At 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 III DSP
Reports to: DSP Supervisor
Group / Division: Pharma Service Group (PSG)
Career Band: Band 4
Job Family: Operations
Job Sub Family: Manufacturing – Formulation (MFGF)
Job Code: OPS.MFGF.P03
Job Track: Professional
Position Location: Brisbane, Australia
Number of Direct Reports: 0
Manufacturing of biopharmaceutical products in compliance with international quality requirements as defined by TGA, FDA, EMEA, ICH, etc.

MINIMUM REQUIREMENTS/QUALIFICATIONS:

Qualifications & Experience
Tertiary education in science or engineering based field (i.e. 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 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.

• 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 DSP Senior Bioprocess Scientist. 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.