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B100 Manufacturing Technology Manager, Process Validation (vaccine production facility)

Toronto, Canada

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Responsibilities

B100 Manufacturing Technology Manager, Process Validation (vaccine production facility)

Reference #: R2499476

Department: B100 Mtech

Location: Toronto, Ontario

About Sanofi Pasteur

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.

Position Summary:

The Manager, Building 100 (B100) Manufacturing Process Validation will report directly to the B100 MTech Deputy Director, Process Validation and LCM, with the following key accountabilities:

  • Manage and lead Process Validation activities pertaining to B100 licensure and lifecycle management within the context of B100 start-up facility project and the MTech project organization.
  • Deliver a strong and comprehensive validation program and package for: media/buffer preparation, antigen preparation and adjuvant manufacturing.
  • Manage and provide technical leadership for the strategy, planning and execution of process validation activities.
  • Manage and support qualification and implementation of single-use applications.
  • Support commissioning and qualification (C&Q) of media and buffer preparation and delivery systems, as well as C&Q of other manufacturing and supporting systems.
  • Support execution of cleaning validation plans.

Key Accountabilities:

Technical Direction and Management

General:

  • Support execution phases of the B100 project (validation, start-up, ramp-up) in coordination with Operations, Technical services, Quality and RA.
  • Lead/build process validation team to assure the required discipline for successful execution/ completion of deliverables. 

Manage and provide Process Validation expertise for Media and Buffer Process and cP, Dip and Tet Antigen Processes:

  • Ensure the development of effective and consistent process for preparation of buffers and media and antigens with new equipment and SUT.
  • Ensure comprehensive mixing studies, establishing validated conditions (duration, mixing speed, temperature, etc.).
  • Filtration validation (fit for use for process conditions, retention, binding, compatibility, etc.).

Support Single-Use Technology implementation and provide guidance to validation teams and users, including any outsourcing activities:

  • Ensure preparation, review and approval of protocols and reports as per project schedule.
  • Oversee/prepare Media and Buffer process validation master plan and support planning and execution of other validation plans (for cP, Dip and Tet).
  • Drive/Lead execution of validation processes,  ensuring preparation, review and approval of protocols and reports as per project schedule.
  • Commissioning and Qualification of Cleaning Systems.
  • Working closely with C&Q, Automation and Process Engineering leads to support assessment of system integration, flow path sequencing, and recipe development.
  • Support development and execution tests for SAT and Qualification of CIP skids and their target systems.

Transversal Expertise and Management:

  • Support execution phases of the project (validation, start-up, ramp-up) in coordination with Operations, Technical Services, Quality and RA.
  • Manage Process Validation team to assure the required discipline for successful execution/ completion of deliverables. 
  • Lead Media and Buffer preparation and antigen manufacturing and validation to assure the required discipline for successful execution/ completion of deliverables .  
  • Apply sound project management tools to track execution, cost and earned-value analysis.

Education and Experience:

  • Master or Ph.D preferred, BSc with 5+ years demonstrated leadership (project/people management).

  • Minimum 8-10 years direct experience in biotech pharma/biotech manufacturing, and quality environments in a process validation role.

  • 5+ years demonstrated leadership in behavioral competencies and project/people management.

  • Senior technical experience and specialist expertise in process validation including cleaning validation, media and buffer validation and filter validation.

  • Strong understanding and direct experience with single use technology, including implementation and validation of single use systems.

  • Sound knowledge in biochemistry and protein chemistry is an asset.

  • Ability to communicate and work with a very broad spectrum of professional and technical staff to effectively manage in an efficient and practical manner.

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          

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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