Reference No. R2740534

Position Title: Technical Group Leader - Vaccines

Duration: Fixed Term, Contract End Date April 30, 2027

Department: cP Team 3

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 Upstream production activities:

• Scheduleand coordinate daily/weekly work of a group of technicalstaff in theUpstream area.

• Check and review BPR, SOP, logbooks, and monitoring charts for completion and insurance of accuracy of all documents as per GMP guidelines.

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

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

• Train and ensure technical staff comply to cGMP, HSE, and SOP requirements.

• Facilitate daily meetings and report findings to management.

• File quality notifications and participate in lead investigations.

• Coordinate activities within CP department (Downstream and MWS) and outside departments (maintenance, washing and sterilization, media, QO test labs) and ensure timely completion of production support activities.

Health, Safety, Environment:

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

• Drive culture of HSE in department.

• 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.

• Promote waste and environmental awareness using 3Rs (Reduce, Reuse, Recycle).

Fermentation and harvest of B.pertussis for cP antigens production:

• Microbiology manipulations in a BioContainment Cabinet (BCC)

• Preparation and operation of seed and intermediate fermenters

• Preparation and operation of production fermenters

• Operation of a centrifuge to harvest the fermentations.

• Preparation and operation of Microfilters and Ultrafilters

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

Administration of Data Information for CP Production:

• Coordinate and oversee technicalstaff completion in SAP activities.

• Capacity planning,budgeting and scheduling of materials and personnel (MPS,

• MRP)

• Create and maintain master recipes and production inventory.

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

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

• Confirm inspection characteristics for batches, perform Stock Posting when needed.

• Perform Pharm Net Web activities.

• Ensure all data input is completed accurately and in a timely manner such as Shop Floor Data, LIMs, Master, Change Request Forms.

Process improvement and development:

• Coordinate and schedule work of technical staff in facility, equipment, and process improvement projects with Manufacturing Technology (MTech) and facility management (GEM)

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

• Write specifications, protocols and reports related to facility, equipment, and process improvement of production process.

• Modification of SOPs and BPRs for new processes in accordance with change control policies.

• Perform IQ, OQ, and PQ for new equipment.

• Attend meetings with other support functions representing production as needed.

Preparation of Trending reports and SPC data analysis:

• Monitor and analyze production process and test data, launch investigation for out of trend, alert management and Manufacturing Technology

• Maintain test result and process database, assist in preparation of root cause SPC analysis reports.

• Collaborate with other department functions (QO, MTech) for root cause analysis and present findings.

• Assist with implementation of corrective actions in production.

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

Housekeeping:

• Ensureproductionareaiskeptinatidy,GMPmanner,following5Sguideline(sort, straighten, shine, standardize, sustain).

• Disinfect area as required in SOP.

• Coordinate with various team members to ensure loading dock and hallways are clean and unobstructed by materials or equipment, garbage is discarded daily to designated area outside production.

• Ensure office area is kept in a tidy clean manner.

• Propose to management ways of improvement.

• Animate visual management tools.

Minimum Qualifications:

• Minimum four (4) years bachelor's degree (Biochemistry, Microbiology, Bioengineering), plus a minimum of four (4) years of previous relevant work experience.

• Preferred two (2) years master's degree (Biochemistry, Microbiology, Bioengineering), plus a minimum of three )3) years of previous relevant work experience.

• SoundKnowledgeofMicrobiology

• SoundknowledgeofFermentation

• AsepticTechniques

• Chemistry & Mathematics

• cGMP

• cGLP

• Basicmechanicalskillandknowledge

• Computer Skills; SAP, Visio, Autocad, MS Access, JMP                                                       

• Decision making & delegation, Initiative, Leadership Skills

• Technical Writing

Hours Of Work:

• Inclusive from Saturday & Sunday - Friday: 6:00 am - 2:00 pm & Monday - Wednesday: 2pm -10pm

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 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 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.

Only those candidates selected for interviews will be contacted.

Follow Sanofi on Twitter: @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 and check out our Diversity Equity and Inclusion actions at sanofi.com!