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Sanofi Group Technical Group Leader, Downstream - Vaccines in Toronto, Ontario

Reference No. R2742803

Position Title: Technical Group Leader, Downstream - Vaccines

Duration: Fixed-Term - Contract End Date: May 14, 2027

Department: B200 Downstream Day Shift 1

Location : Toronto, Ontario

Sanofi Vaccines

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.

Major Activities of the Job:

Administration of Influenza manufacturing activities:

  • Schedule and coordinate daily/weekly work of a group of technical staff in B200 as per area requirements.

  • Check and review Records, SOP, logbooks/e-logbooks, BPRs/e-BPRs, and monitoring charts for completion and accuracy of all documents as per GMP guidelines.

  • Ensure equipment is kept in good GMP condition (with preventive maintenance, validation and calibration)

  • Order and ensure adequate chemicals, supplies, and spare parts for equipment.

  • Train and ensure technical staff comply to GMP and SOP requirements.

  • Facilitate daily meetings and report findings to management.

  • Initiate and file deviations and lead investigations.

  • Coordinate and support units within department (Upstream, Downstream, MWS) and other outside departments (Maintenance, Automation, QO test labs, etc.) and ensure timely completion of production activities.

  • Perform other duties as assigned by Department Management throughout all stages of drug substance manufacturing.

  • Supervise material handling in B200 Shipping, Receiving, and storage areas.

Administration of Data for Influenza manufacturing:

  • Coordinate, oversee, and confirm technical staff’s completion of SAP activities/transactions.

  • Capacity planning and scheduling of materials and personnel.

  • Create work orders for ETS/Maintenance.

  • Maintain master recipes and production inventory.

  • Create and maintain process orders with authorization to change orders upon demand.

  • Ensure transactions are done in a timely, accurate manner.

  • Oversee and support activities in required environmental monitoring systems.

  • Ensure all data input is completed accurately and in a timely manner such as investigation data, LIMs, deviation filing, change request forms, etc.

  • Perform activities in PCS and review data as required.

Perform and oversee area specific activities, monitoring, maintenance:

  • Perform and delegate 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 and delegate utility sampling and environmental monitoring as required and ensure completion on schedule.

  • Train technical staff on problem solving and troubleshooting as required.

  • Ensure area is inspection ready. Knowledgeable to guide inspectors.

  • Perform activities as needed based on access levels on equipment.

Oversight of Health, Safety, and maintenance of GMP environment:

  • Train and ensure technical staff comply with HSE requirements.

  • Ensure operators are equipped and use proper PPE when performing tasks.

  • Actively participate in activities done by HSE department and support HSE initiatives.

  • Ensure operations are performed in an ergonomic way and escalate any potential hazards. Help develop proposed solutions.

  • Ensure routine HSE checks and inspections are completed in a timely manner.

  • Ensure cleaning chemicals and equipment are stored and used as per HSE requirements and have SDS available.

  • Ensure production and office areas are kept in a tidy, GMP manner, following 5S guideline or equivalent.

  • Clean and disinfect areas as required in SOP.

Process improvement, development and preparation of trending reports:

  • Coordinate and schedule work of technical staff in facility, equipment, and process improvement projects with Manufacturing Technology (MTech) and facility management (Engineering & Technical Services).

  • Assist implementation of facility, equipment, and process improvement projects.

  • Write or modify specifications, protocols and reports related to facility, equipment, including SOP’s, BPR’s.

  • Perform activities involved in IQ, OQ, and PQ for new equipment.

  • Initiate CCR, CAPA in Quality system as needed and manage them until completion as per committed due dates.

  • Collaborate with other departments for root cause analysis and assist with implementation of corrective actions.

Minimum Qualifications:

  • Minimum three (3) years College Diploma (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science Degrees.) plus a minimum of three (3) years of previous relevant work experience.

  • Preferred (4) years bachelor’s degree (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science Degrees.) plus a minimum of three (3) years of previous relevant work experience.

  • Sound Knowledge of Microbiology, protein purification, mechanical skill and knowledge, Aseptic Techniques, Chemistry, cGMP.

  • Familiarity with Automated and manually operated process equipment.

  • Strong knowledge of Computerized systems, Data management systems, Quality management systems, SAP, SOPs, automation, and other software/applications.

  • Strong communication, Interpersonal, Leadership & Decision making and delegation skills.

Hours Of Work:

  • Inclusive from Monday to Friday: 8:00 a.m. - 4:00 p.m. (Subject to change)

This is subject to change at any time, and it should not be construed as limiting the right of the company to make such change to meet the requirements of the operation.

Pursue Progress.

Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity, Equity and Inclusion actions at www.sanofi.com !

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to a ttract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

Follow Sanofi on Twitter: @SanofiCanada (https://twitter.com/SanofiCanada) and on LinkedIn: https://www.linkedin.com/company/sanofi

#GD-SP #LI-SP

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

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