Bioprocess Scientist
1 month ago
Work Schedule and Environmental Conditions
Our ideal candidate will work a 12-hour shift, with a focus on maintaining a clean and safe environment. This includes adhering to Good Manufacturing Practices (GMP) safety standards, wearing personal protective equipment (PPE), and standing for the full shift.
Job Summary
At Thermo Fisher Scientific, we're committed to enabling our customers to make the world a healthier, cleaner, and safer place. As a Bioprocess Scientist - Manufacturing Specialist, you'll play a critical role in manufacturing biopharmaceutical products that meet international quality requirements.
Key Responsibilities:
- Support the execution of DSP unit operations, including chromatography, virus inactivation, and ultrafiltration-diafiltration, in a clean room environment under cGMP conditions.
- Identify and communicate practical problems to the responsible person, demonstrating a proactive attitude and personal initiative.
- Maintain production suites, supplies, equipment, logbooks, and data, as well as close out batch records and material reconciliation in accordance with site SOPs and policies.
- Perform equipment maintenance and testing related to technical skills of Bioprocess Scientist DSP, and support the implementation of new procedures and/or equipment in the OPS department.
- Revise and author SOPs and logbooks, adhering to Patheon cGMP Quality Management System and EH&S requirements.
- Complete corrective and preventive actions, contribute to deviation investigations, and support the timely closure of deviation reports and change controls.
- Implement lean (OE) initiatives and continuous improvements, and contribute to the transfer and understanding of specific new technologies to DSP.
- Connect with suppliers regarding technical issues.
Minimum Requirements/Qualifications
Qualifications & Experience
Either experience in the pharmaceutical industry or tertiary education in a science or engineering-based field (i.e. biopharmaceuticals manufacture, biotechnology, process technology).
Good understanding of cGMP practices.
Skills & Attributes
Ability to work unsupervised, good communication, flexibility, reliability, and assertiveness. Responsible and proactive.
Other Job Requirements
Your position may require you to be on shift or on call, with 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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