Technical Group Leader Jobs

Reference No. R2705681
Position Title: Technical Group Leader
Duration: Fixed-Term Contract, (September 18 - August 16, 2024. Potential for extension)
Department: Flu Operations
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:

• 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.
• Train and ensure technical staff comply to GMP and SOP requirements.
• Schedule and coordinate daily/weekly work of a group of technical staff in B200 as per area requirements.
• Facilitate daily meetings and report findings to management.
• Ensure equipment is kept in good GMP condition (with preventive maintenance, validation and calibration)
• Perform other duties as assigned by Department Management throughout all stages of drug substance manufacturing.
• 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.
• Supervise material handling in B200 Shipping, Receiving, and storage areas.
• Order and ensure adequate chemicals, supplies, and spare parts for equipment.
• Initiate and file deviations and lead investigations.

Administration of Data for Influenza manufacturing:

• Oversee and support activities in required environmental monitoring systems.
• Coordinate, oversee, and confirm technical staff’s completion of SAP activities/transactions.
• Perform activities in PCS and review data as required.
• Maintain master recipes and production inventory.
• Create and maintain process orders with authorization to change orders upon demand.
• Create work orders for ETS/Maintenance.
• Capacity planning and scheduling of materials and personnel.
• Ensure transactions are done in a timely, accurate manner.
• Ensure all data input is completed accurately and in a timely manner such as investigation data, LIMs, deviation filing, change request forms, etc.

Perform and oversee area specific activities, monitoring, maintenance:

• Train technical staff on problem solving and troubleshooting as required.
• Ensure area is inspection ready. Knowledgeable to guide inspectors.
• Perform and delegate production calculations, measurements and release checks. Ensure each cleaning meets standards set in SOP, records, and in accordance with GMP.
• Perform and delegate utility sampling and environmental monitoring as required and ensure completion on schedule.
• Perform activities as needed based on access levels on equipment.
• Observe in detail and report any process deficiencies, perform visual inspection of equipment for impurity and damage before and after cleaning.

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

• Ensure cleaning chemicals and equipment are stored and used as per HSE requirements and have SDS available.
• Train and ensure technical staff comply with HSE requirements.
• Actively participate in activities done by HSE department and support HSE initiatives.
• Ensure production and office areas are kept in a tidy, GMP manner, following 5S guideline or equivalent.
• Ensure operators are equipped and use proper PPE when performing tasks.
• Clean and disinfect areas as required in SOP.
• Ensure routine HSE checks and inspections are completed in a timely manner.
• Ensure operations are performed in an ergonomic way and escalate any potential hazards. Help develop proposed solutions.

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).
• Write or modify specifications, protocols and reports related to facility, equipment, including SOP’s, BPR’s.
• Assist implementation of facility, equipment, and process improvement projects.
• Initiate CCR, CAPA in Quality system as needed and manage them until completion as per committed due dates.
• Perform activities involved in IQ, OQ, and PQ for new equipment.
• Collaborate with other departments for root cause analysis and assist with implementation of corrective actions.

Minimum Qualifications:

• Strong communication, Interpersonal, Leadership & Decision making and delegation skills.
• 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.
• 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.
• 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.
• Sound Knowledge of Microbiology, protein purification, mechanical skill and knowledge, Aseptic Techniques, Chemistry, cGMP.

Hours Of Work:

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

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 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
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.