Technical Group Leader

Reference no: R2863191

Position title: Technical Group Leader

Duration: Fixed Term Contract - 11.5 months

Location: Toronto, ON

Join a global network that powers how Sanofi delivers – seamlessly, purposefully, and  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.

• Direct daily/weekly work of technologists and advanced technicians in the Production Area.
• Prepare and/or approve detailed calculations for Adsorption of CP Antigens Diphtheria and Tetanus Toxoids with or without 2-PE.
• Assist/verify Adsorptions by addition of APW suspension using electronic scales bench/floor models.
• Assist/verify Adsorption of CP Antigens, Diphtheria and Tetanus Toxoids without 2-PE by weighing/measuring, sterile filtering and integrity testing.
• All products Adsorbed are prepared in a clean room using aseptic technique and strict adherence to cGMP throughout operations.
• Monitor all parameters which indicate status of clean room, such as daily cleaning logs, FMS, particle counts and environmental incidents for accuracy and ensure all cGMP requirements have been met.
• General laboratory and equipment maintenance, arrange repairs as required, and troubleshoot to facilitate timely repairs.
• Maintain cleanroom to meet GMP requirements including validation, personnel training, daily cleaning and monitoring activities.
• Assist in validation of the Cleanroom, perform process validation and aseptic process validation for Adsorbed Products as required; assist in generation and execution of IQ, OQ, and PQ protocols for validation of all equipment used for Adsorptions.
• Train new staff in hands‑on use of equipment, manage equipment, material and personnel flow for the production area and building, and all environmental monitoring of the Clean rooms.
• Designated trainer for area tasks.
• Preparation of area for regulatory inspections, act as back‑up contact for Manager.
• Maintain Adsorption Inventory accuracy in SAP system, perform timely transactions for production batches and participate in weekly cycle counts.
• Maintain Class A status through auditing and revising recipes and master data as required.
• Manage inventory levels of concentrates and Adsorbed Antigens required for the Formulation of Final Products; review temperature records and respond to all alarms.
• Inform Manager of inventory changes through completing a cycle count and/or root cause analysis, initiate e‑MAF forms as required for managing expired inventory.
• Prepare weekly and monthly production plan from SAP system with Manager; schedule media and equipment supplies with the Media and Washing & Sterilizing departments daily, weekly, and monthly.
• Plan daily work schedule for production staff detailing work required to be completed.
• Maintain communication with FF&P to ensure weekly Adsorbed antigen requirements are met, attend inter‑departmental meetings in the absence of Manager.
• Co‑ordinate movement of Released Adsorbed products to FF&P storage location and ensure all relevant documentation is completed in a cGMP‑compliant manner.
• Work with Sample Management to ensure all samples are delivered to labs correctly; act as final check to technologists and advanced technicians preparing samples for the lab.
• Conduct daily PC Board meetings.
• Review completed BPRs to ensure completeness and all cGMP requirements are met; review all environmental data and test results to ensure required parameters are met.
• Revise SOPs and BPRs as required when processes or testing requirements change.
• Work with QO‑OQ department and Regulatory Affairs department to ensure expeditious…