Quality Control Analytical Expert

Job Description

**Reference No.** R2839625**Position Title:** Quality Control Analytical Expert**Department:** Biological Testing Support**Duration:** Fixed term Contract End Date January 31, 2027 **Location:** Toronto, Canada**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.The Analytical Expert in Analytical Excellence (AE) is is primarily responsible for ensuring the validated state of QC test methods, incorporating a life-cycle methodology for test method assessment, protocol design and execution, and coordination of all associated laboratory activities. The incumbent will ensure test method accuracy through review of control charts, and conduct scientific investigations into causes of aberrant test results. The individual is also responsible for providing oversight and support to test transfers into and out of QC and for enabling the introduction of new technologies into QC.**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:*** Provide contributions to the understanding and interpretation of results and how they impact the design of subsequent experiments.* Design, execute, and interpret experiments to develop, validate, transfer and troubleshoot quality procedures and test methods. Carries out investigations and produces documentation.* Develop and authors complex, explicit documentation for new and current procedures, validation protocols and technical reports incorporating appropriate use of statistics.* Solve assay/process problems.* Identify potential problems and proactively suggests technical solutions based upon analytical expertise and knowledge of product/process.* Coordinate completion of specific project tasks with other departments.* Contribute to development of project strategy in consultation with supervisor and/or colleagues.* Work is performed under minimal supervision. Independently determines and develops approach to solution.* Obtain results or erroneous decisions or recommendations would typically result in program delays and expenditure of resources.* Represent the organization in providing solutions to difficult technical issues associated with specific projects.* Support laboratory activities if required**Responsibilities in test method validation include:*** Lead method optimizations, improvements and re validation.* Lead ALCM method assessment periodic review.* Address method validation gaps identified during ALCM method assessment periodic review.* Address validation/testing gaps for new products.* Support/Lead replacement of test methods with new test/technology.* Support/Lead implementation of new tests/technology.* Support/Lead post approval commitments and other regulatory commitments.**About You****Key Requirements:*** Bachelor’s degree with a minimum of 7 years of relevant experience, or Master’s degree with a minimum of 3 years of relevant experience, or Ph.D. with a minimum of 2 years of relevant experience (Immunology/Biology preferred)* Experience performing immunology assays (e.g., ELISAs and cell-based bioassay methods)* Outstanding technical writing skills (protocols, reports, investigations)* Experience in test method validation and troubleshooting* Strong organizational skills with the ability to manage multiple projects simultaneously* Experience conducting scientific investigations, including OOS investigations and CAPAs* Strong communication skills with the ability to collaborate and lead teams* Experience in animal testing preferred* 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 programsApplications received after the official close date will be reviewed on an individual basis**This position is for a current vacant role that we are actively hiring for.****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, . The 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.#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 and check out our Diversity Equity and Inclusion actions at !*North America Applicants Only*The salary range for this position is:$76,200.00 - $110,066.66All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the .La fourchette salariale pour ce poste est la suivante:$76,200.00 - $110,066.66Toute compensation sera déterminée en fonction de l'expérience démontrée. Les employés peuvent être admissibles à participer aux programmes d'avantages sociau de l'enterprise. Des informations supplémentaires sur les avantages sont disponibles via le .
#J-18808-Ljbffr