Upstream Technologist -Clinical Manufacturing

Upstream Technologists to support Clinical Manufacturing Platform
Vaccine Manufacturing
Full-time, Toronto

Responsibilities:

• Assist with development of new vaccine processes
• Assist with the preparation of reports summarizing experimental and assay results
• Support the transfer and / or implementation of new technologies / equipment / processes for Bacterial and / or Viral vaccines
• Support GMP production of the Clinical Drug Substance for viral and bacterial antigens in CMP facilities
• Assist with preparation of SOPs, master BPRs, & validation protocols. Assist with preparation of Manufacturing Record Files (MRFs)
• Support Environmental Monitoring through sampling activities

Requirements:

• Need at least some experience with Upstream processes (Bacterial fermentation, continuous centrifugation etc.)
• Sounds knowledge of cGMPs
• Ability to gown-up and wear mask and gloves
• Need to be comfortable working in area surrounding with machinery, steam and compressed air systems
• Level: intermediate to Senior
• Shift: Day shift mostly, may need some flexibility to work longer hours at times
• Education: Postgraduate or bachelor degree in Biochemistry, Microbiology or Bioengineering

Additional notes from the manager
• Experience running fermenters
• Ability to help troubleshoot the fermenter would be great
• Experience with Centrifuges, filtration skids, homogenizers etc.
• Manufacturing experience is important, much more restrictions and compliance requirements than in a lab
• Current fermenters at Sanofi are 200L and 20L however relevant experience with small scale bacterial fermenters (10/20L) would be relevant (someone who knows the different controls, the types of probes they have, how the sterilization process works etc.)
• Bioreactors are different but good bioreactor experience could be relevant (experience with “shake flasks” would NOT be relevant)