Reference no: R2863191
Position title: Technical Group Leader
Duration: Fixed Term Contract - 11.5 months
Location: Toronto, ON
About the Job
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.
About Sanofi
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main Responsibilities:
Adsorption of CP Antigens, Diphtheria and Tetanus Toxoid with or without 2-PE
• 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 in the Adsorptions by addition of APW suspension by use of electronic scales bench /floor models.
• Assist/verify in the 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. This requires special work conditions and environment.
• Monitoring all parameters which indicate status of clean room (i.e.) monitor daily cleaning logs, FMS, review and sign off particle counts and environmental incidents for accuracy and ensure all cGMP requirements have been met.
• General Laboratory and equipment maintenance, arrangement of repairs as required. Troubleshooting where possible to facilitate timely repairs.
Maintain cleanroom to meet GMP requirements including validation, personnel training and daily cleaning and monitoring activities
• Monitor all parameters which indicate status of Cleanroom (i.e.) monitor cleaning logs, FMS daily; review and sign off particle counts and environmental incidents for accuracy and ensure all cGMP requirements are met
• 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. Equipment, material and personnel flow for the production area and bldg and all environmental monitoring of the Cleanrooms.
• Designated trainer for area tasks
• Preparation of area for regulatory inspections, act as back-up contact for Manager
Maintenance of SAP system with close attention to inventory levels
• Maintain Adsorption Inventory accuracy in SAP system by performing timely transactions for production batches and through participation 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. Bulk Mfg Adsorptions dept is the owner of several walk-in refrigerators, located in Bldg 90. 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.
Daily assignment of work to Adsorption Personnel, assist in production planning
• Prepare weekly and monthly production plan from SAP system with Manager. Schedules media and equipment supplies with the Media and Washing & Sterilizing departments daily, weekly, and monthly. Inform Manager of any changes and incidents for action.
• Plan daily work schedule for production staff detailing the 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 right first time cGMP 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 going to the lab.
• Conduct daily PC Board meetings.
Maintains documentation including Reviewing BPRs, SOPs, process descriptions
• 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 as processes and/or testing requirements are changed and improved
• Work with QO-OQ department and Regulatory Affairs department to ensure expeditious changes to documents.
• Participate in Change Control planning and implementation, and management of CAPA actions
Monitoring and Analysis of Production Batches
• Review test results to ensure that they are within specification.
• Trend test results to observe any deviations in process which are then communicated to the supervisor and QA/RA as required
No employee has a proprietary right to an activity or group of activities. Activities may be changed or reassigned to meet the needs of the operations.
About You
Minimum Qualifications:
• Minimum 4 years Bachelor's in Science degree (Microbiology, Chemistry, Biochemistry), plus a minimum of 2 (two) years of previous relevant work experience.
• Preferred Master's in Science degree (Microbiology, Chemistry, Biochemistry), plus a minimum of 1 (one) year of previous relevant work experience.
Hours Of Work:
• Inclusive from Monday to Friday 2:00pm-10:00pm
This is subject to change at any time and it should not be construed as limiting the right of the company to make such a change to meet the requirements of the operation.
Mandatory Application Requirement: Your Workday application form must be complete, and a copy of your resume MUST be attached in the Workday application form, at the time you submit your Workday application, otherwise your application will not be considered for this position.
Pay rate - $54.52 per hour
Why Choose Us?
• Bring the miracles of science to life alongside a supportive, future-focused team.
• 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.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs
Applications received after the official close date will be reviewed on an individual basis.
AI Usage
"Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learning, to analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identify patterns, improve services, or support decision-making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company’s Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concern regarding your personal information. You can also contact Canada’s Privacy Officer via Sanofi’s data subject request portal, Data Subject Rights Webform. The Data Subject Rights Webform can also be used to request access or correction of your personal information and file a complaint.
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, 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. #GD-SP #LI-SP #LI-Onsite
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 and check out our Diversity Equity and Inclusion actions at sanofi.com!