B100 DT Upstream Technologist

Sanofi • Toronto, ON

2d • Onsite

About The Position

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being. At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

Requirements

• Minimum (3) three years College diploma (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science, or equivalent) plus a minimum of (2) two years of previous relevant work experience.
• Fermentation Process for cP bacteria
• Production Equipment
• Aseptic Technique
• Current Good Manufacturing Practices (cGMPs)
• Knowledge and experience in Chemistry, Microbiology, Biochemistry Mathematics, Computer, Mechanical Aptitude, Technical Writing, Quality and Improvement, Safety

Nice To Haves

• Preferred (4) four years Bachelor's degree (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science, or equivalent) plus a minimum of 18 months of previous relevant work experience.

Responsibilities

• Execution of Upstream activities of drug substance
• Assist in review of Records, SOP, and logbooks for completion and ensure accuracy of all documents as per GMP guidelines.
• Participate in daily meetings and report findings to management.
• Participate in deviation investigations and root cause analysis.
• Coordinate with units within department (MWS, Upstream and Downstream)
• Provide training to personnel.
• Participate in IQ/OQ/PQ validation and cleaning verification protocols.
• Ensure all equipment, instruments and systems are properly assembled, installed, tested and maintained.
• Preparation of inoculum, analytical testing, area monitoring (utility sampling, environmental monitoring), maintenance, material handling, warehouse
• Perform activities and documentation involved in Upstream including, in buffer preparation, inoculation preparation, fermentation, harvest, FIM antigen related processing and material handling using MES/PCS system.
• Perform production calculations, measurements, and release checks.
• Ensure each cleaning meets standards set in SOP, records, and in accordance with GMP.
• Observe in detail and report any process deficiencies, perform visual inspection of equipment for impurity and damage before and after cleaning.
• Perform utility sampling and environmental monitoring as required and ensure the completion as adhered to schedule.
• Ensure area is inspection ready.
• Administration of data for drug substance operations and preparation of trending reports for SPC analysis
• Document, review production and monitoring activities for cP & DT drug substance manufacturing
• Complete SAP transactions in a timely, accurate manner.
• Draft, review and revise various cGMP documents (SOPs/SWls, batch records, protocols, change controls, reports and other manufacturing supporting documents).
• Analyze, enter & verify data on paper based or electronic documents.
• Participate in keeping the production area and office areas in a tidy, GMP manner, following SS guideline or equivalent and supply materials as required
• Disinfect area as required in SOP.
• Assist to ensure loading dock and hallways are clean and unobstructed by materials or equipment, garbage is discarded daily to designated area outside production.
• Use proper PPE when performing tasks.
• Follow HSE SOP's, identify and minimize risks, promote safety culture.
• Ensure chemicals are stored as per HSE requirement and has SDS available.
• Participate in process improvement and equipment improvement, and Quality and Inspection readiness initiatives.
• Assist implementation of facility, equipment, and process improvement projects
• Assist in writing specifications, protocols and reports related to facility, equipment, and process improvement of production process
• Modification of SOPs and BPR's for new processes in accordance with change control policies
• Perform activities involved in IQ, OQ, and PQ for new equipment
• Initiate Deviations, CCR, CAPA in Quality system as needed and assist until completion as per committed due dates
• Collaborate with other departments for root cause analysis and assist with implementation of corrective actions

Benefits

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree