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Manager, Sterility Assurance (new vaccine facility)

Toronto, Canada

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Responsibilities

Position Title: Sterility Assurance Manager Building 100 (B100 new vaccine facility)

Department: Sanofi Pasteur, Toronto/Site Quality Operations

Position Summary:

The Sterility Assurance Manager is responsible for ensuring all sterility assurance related activities for the B100 project phase are developed, managed, followed and sustained for eventual routine manufacturing operations. The incumbent is expected to provide direction and guidance for sterility assurance related matters encountered as part of the overall project. Additionally, liaising between the project team and routine sterility assurance operations will be required as part of the role.

Key Accountabilities:

  • Design, develop, document and manage microbial control strategy for the facility and production processes, from incoming raw materials through final product release.
  • Provide guidance, oversight and support relating to sterility assurance issues for Operations, Engineering and other QA personnel.
  • Provide sterility assurance expertise to support deviations, CAPAs and change controls during the qualification phase of the project.
  • Perform preparatory activities to support eventual PAI for the facility; act as sterility assurance SME during regulatory audit.
  • Provide microbiological and sterility expertise for the qualification documents including,: protocols, specifications, SOPs
  • Manage a team of environmental/critical utility samplers.

Serve as liaison between project team and routine sterility assurance & QC microbiology group in terms of:

  • Qualification sample management (EM & utility samples)
  • Assessment of required test method verification/validation
  • Sterility assurance program integration

Education and Experience:

  • Bachelor’s degree, with a scientific/engineering discipline
  • Min 5 (five) years of relevant experience in pharmaceutical or biological manufacturing
  • Experience with designing environmental and critical utility monitoring programs
  • Experience with designing aseptic process simulation programs
  • Experience with investigating environmental and critical utility monitoring deviations
  • Experience with designing contamination control programs and policies
  • Experience with facility start ups is desirable
  • A highly capable problem-solver with strong leadership and management capabilities

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 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.

Sanofi, Empowering Life

#GD-SP  #LI-SP

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.

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