Sanofi Group Manager, Chemistry Testing in Toronto, Ontario
Reference Number: R2569241
Position Title: Manager, Chemistry Testing
Location: Toronto, Ontario
The Manager of QC Chemistry is responsible to optimally manage high volume testing of vaccine components and products by a team of analysts, ensuring compliance with cGMP and Quality Systems. The individual will oversee day to-day operation of the area within their responsibility including personnel activities, capacity management, testing workflow, technical oversight and troubleshooting. The Manager is to ensure that all regulatory commitments are met and that resources and test methods are continually monitored to meet demand forecast. The Manager participates as business owner in equipment and software upgrade projects for tests under their responsibility.
Supervise and coordinate daily operations to ensure on time testing while ensuring compliance.
Co-ordinate staff daily activities and work schedules of 6-8 direct reports to ensure prompt and accurate testing.
Establish and communicate testing priorities within area of influence in a timely manner.
Conduct scientifically sound investigations into atypical or out-of-specification test results with an emphasis on finding and addressing root causes and propose corrective actions.
Ensure that test protocols and SOPs are implemented and followed in accordance with cGMP guidelines.
Accountable for ensuring on time delivery of completed test documentation. Responsible for implementing and maintaining Quality Systems within the department in order to align with divisional objectives.
Ensure tests are completed and all test-related documentation, including LIMS, is reviewed by analysts in a timely manner.
Review test documentation for accuracy and compliance with current testing procedures and regulations, and approve test results in a timely manner.
Ensure that electronic instruments meet data integrity requirements.
Maintain validation status of test methods; monitor assay performance and accuracy through trending.
Accountable for ensuring optimal scheduling and capacity planning of work groups to maximize efficiencies.
Ensure optimal scheduling and cross-training in place to maximize efficiencies and reduce test cycle time, using LEAN methodology.
Develop, refine and implement process changes to ensure optimal scheduling and capacity planning is maintained.
Work closely with planners to identify testing priorities and ensure on time testing of products.
Improve and optimize testing procedures through test modifications and replacement, while investigating cost reduction measures.
Refine and optimize test procedures to ensure most cost effective and efficient means are being utilized while ensuring compliance.
Benchmark with others in the industry to gain knowledge of standard practices being utilized.
Actively network with global counterparts in the US and France on common issues.
Education & Experience:
Minimum Master of Science in Chemistry/Biochemistry or a related field, such as Biomedical Sciences, with 5 (five) years previous experience in a high volume laboratory setting is required.
OR Minimum Bachelor of Science degree and 8 (eight) year previous experience in a high volume laboratory setting is required.
Knowledge of Data Integrity requirements with respect to electronic data
Experience with methods including: titrimetric analysis; physico-chemical methods, e.g. pH, conductivity, osmolality; TOC, UV-VIS, GC, HPLC, HPAEC, LC-MS; SDS-PAGE and Western Blot.
Experience in working with biological materials including proteins and antibodies, knowledge of biosafety.
Previous leadership/supervisory experience.
Strong organizational, communication and problem solving skills are also required together with sound statistical knowledge and computer literacy.
Sanofi Pasteur: The world’s leading vaccine company
Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to a ttract, 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.
Sanofi, Empowering Life
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.