Overview
Technical Group Leader Jobs in Toronto, Canada at Sanofi
Overview
Technical Group Leader – Fixed Term Contract (11.5 months) based in Toronto, ON. The role leads a team of technologists and advanced technicians in the Adsorption of CP Antigens, Diphtheria and Tetanus Toxoids, ensuring clean‑room GMP compliance, inventory accuracy, schedule planning, and regulatory support within Sanofi’s Manufacturing & Supply Vaccines Unit.
Responsibilities
- Adsorption Operations
- Prepare and approve detailed calculations for Adsorption of CP Antigens, Diphtheria and Tetanus Toxoids with or without 2‑PE.
- Assist or verify adsorption steps using electronic scales, bench/floor models, APW suspension, sterile filtering, and integrity testing.
- Ensure aseptic technique and strict cGMP adherence during all product preparation in the clean room.
- Cleanroom Monitoring & Maintenance
- Monitor daily cleaning logs, FMS, particle counts, and environmental incidents for accuracy.
- Maintain cleanroom GMP requirements, including validation, personnel training, and daily cleaning/monitoring activities.
- Coordinate general laboratory and equipment maintenance, arrange repairs, and troubleshoot to facilitate timely fixes.
- Validation and Documentation
- Assist in cleanroom validation and aseptic process validation for adsorbed products.
- Generate and execute IQ, OQ, and PQ protocols for equipment used in Adsorptions.
- Review, revise, and audit SOPs, BPRs, and process description documents to meet cGMP standards.
- Inventory & Planning
- Maintain SAP inventory accuracy, perform timely transactions, and participate in weekly cycle counts.
- Manage inventory levels of concentrates and Adsorbed Antigens required for final product formulation.
- Review temperature records for walk‑in refrigerators, initiate e‑MAF forms for expired inventory, and perform root‑cause analysis as needed.
- Staff Coordination & Training
- Assign daily work to Adsorption Personnel and produce weekly/monthly production plans with management.
- Provide hands‑on training for new staff and act as back‑up contact for the Manager.
- Conduct daily PC Board meetings and oversee communication with FF&P to meet weekly antigen requirements.
- Regulatory & Inspection Support
- Prepare the area for regulatory inspections and serve as backup contact during audit periods.
- Collaborate with QO‑OQ, Regulatory Affairs, and Sample Management to complete documentation and ensure compliance.
- Production Data Analysis
- Analyze batch test results, trend data, and participate in CAPA actions and change control planning.
- Communicate deviations to supervisors and QA/RA as required.
Qualifications
- Minimum 4 years of experience with a Bachelor’s degree in Microbiology, Chemistry, or Biochemistry.
- Preferred 1 year experience with a Master’s degree in the same fields.
Hours of Work
Inclusive from Monday to Friday, 2:00pm – 10:00pm (subject to change).
Compensation
$54.52 per hour.
Benefits
Competitive healthcare, wellness programs, and a comprehensive rewards package that recognizes contributions and supports work‑life balance.
Equal Opportunity Employment
Sanofi is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified candidates regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, or disability.
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Title: Technical Group Leader
Company: Sanofi
Location: Toronto, Canada
Category:
