Work Schedule
10 hr shift/days

Environmental Conditions
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 -22degrees, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Job Description

About Us:

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the world Healthier, cleaner and Safer! Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 125,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com

• Operate USP unit operations and equipment (Single Use Bioreactors, shake flask, Wave Bioreactors, clarification processes) within a GMP environment flawlessly.
• Independently organize several unit operations in accordance with production protocols and planning schedules in a clean room environment under cGMP conditions.
• Perform equipment testing and troubleshooting as a proven expert in Bioprocess Scientist III technical skills.
• Review, revise, and author manufacturing batch records and material reconciliation.
• Develop and complete validation protocols that require the expertise of a Bioprocess Scientist.
• Strictly adhere to Patheon Biologics cGMP Quality Management System and EH&S requirements.
• Act as SME for specific unit operations or equipment, training and approving on-the-job training for co-workers.
• Lead deviation investigations and change controls to streamline and improve internal processes.
• Propose and implement Corrective and Preventive Actions, supporting the closure of Deviation Reports and Change Controls.
• Lead lean (OE) initiatives and continuous improvements.
• Identify practical problems, propose solutions, and communicate them to the responsible persons.
• Support Department functions, including maintaining production suites, supplies, equipment, logbooks, and data compliance.
• Assist in the transfer and understanding of new technologies to the Operations department.
• Collaborate with collaborators, customers, partners, and team members to implement new procedures and/or equipment.
• Review and write quality GMP documentation.
• Liaise with suppliers on technical issues.
• Perform any additional tasks required for day-to-day operational activities.
• Be available for shift, on-call roster, and scheduled weekend work as required, with appropriate remuneration.
• Adhere to EH&S processes and ensure a safe workplace. Report hazardous conditions, incidents, and participate in EH&S activities.

• Preferably tertiary education in Science or Engineering (e.g., biopharmaceuticals manufacture, biotechnology, process technology).
• Expertise in USP - cell culture passaging, WAVE bioreactors, 50 L - 2000 L stirred tank bioreactors for fed-batch and perfusion process, cell banking, and depth filtration (preferable but not essential)
• Proven track record of thriving in a fast-paced and dynamic working environment.
• Excellent oral and written communication skills and interpersonal skills.

• A competitive salary and performance related bonus structure
• Access to Thermo Fisher's global University
• Exposure to market leading & innovative technologies
• Career development opportunities in a leading global organization