USP Bioprocess Scientist II Full-time

Job Title

Manufacturing of biopharmaceutical products in compliance with international quality requirements as defined by TGA, FDA, EMEA, ICH, etc.

Work Schedule

12 hr shift/days

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc… allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Warehouse, Will work with hazardous/toxic materials

Key Responsibilities

• Trained on and support execution of USP unit operations (cell culture passaging, WAVE bioreactors, 50 L – 2000 L stirred tank bioreactors for fed-batch and perfusion process, cell banking and depth filtration) 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 USP 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 USP. 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 USP.
• Connect with supplier about issues of technical nature.

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 & 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 and 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.