Reference No. R2742367

Position Title: Manager, Stability – Vaccines

Department: Stability and Sample Management

Location: Toronto, Ontario

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as a Manager, Stability within Stability and Sample Management, will be to prepare and execute complaint stability programs for Routine, Initial and Special Study (including change control, clinical, non-clinical and intermediate studies) categories. The incumbent will facilitate all aspects of stability study lifecycles to ensure compliance and timely execution and closure. The Stability Manager will prepare and execute stability data for Department colleagues, Industrial Operations and other departments in order to ensure the submission of new product licenses and control the necessary changes to licensed/marketed products.

Vaccines
We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main responsibilities:

• Prepare and execute initial and special studies; prepare appropriate documentation (e.g. forecasts, protocols, reports).

• Support the timely submission of product license applications, license renewals, license amendments and response to questions, in conjunction with Quality Operations and Regulatory Affairs, through the development and execution of stability strategies and data analysis/interpretation.

• Ensure training is up to date to perform the designated cGMP activities and requirements for Health and Safety.

• Documentation practices must be of superior quality; projects must be undertaken in compliance with internal directives/policies, practices and procedures.

About you

• Strive for Results, Commit to Customers, Cooperate Transversally, Act for Change.

• Bachelor of Science Degree, with specialization in Biology, Biochemistry, Microbiology, Immunology and Chemistry.

• Pharmaceutical experience with related Quality experience in Stability Programs/processes and the associated regulatory requirements

• Excellent knowledge of cGMP for (US, Canada, Japan, China and Europe)

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!