Sanofi Group Deputy Director, Process Validation in Toronto, Ontario

Deputy Director, Process Validation

Reference #: 2459528

Department: Pharmaceutical Sciences & Technology

Location: North York, Ontario

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:

  • Build and lead the cleaning validation team, to support cleaning remediation activities for licensed processes. Lead cleaning validation initiatives related to process improvement projects within the MTech project organization.

  • Deliver a strong and comprehensive validation program and package for cleaning and critical materials, including raw materials, media preparation and single-use technology.

  • Ensure selection of appropriate solutions for single-use technology and robust and consistent cleaning/media/buffer processes.

Key Accountabilities:

Management:

  • Support execution phases of the project (validation, start-up, ramp-up) in coordination with Operations, GEM, Quality and RA

  • Lead/build process validation team to assure the required discipline for successful execution/ completion of deliverables

  • Network with local and global experts/ SPPs as necessary, leveraging knowledge/data where possible

  • Assist with the discussions and interactions with the regulatory agencies where required

Single-Use Technology and Extractables & Leachables Evaluation:

  • Lead evaluation/suitability of use for SUT solutions (e.g. filters, tubing, connectors, containers, etc.) for 5acP, Diphtheria and Tetanus processes

  • Drive the L/E master plan & strategy

  • Prepare risk assessment and gap analysis

  • Establish program for method development, validation and stability studies

Cleaning Validation:

  • Oversee/prepare cleaning validation master plan related to process improvement projects

  • Lead the cleaning validation remediation project for licensed products

  • Drive cleaning validation program (e.g. residue ID, equipment characterization and bracketing/grouping, worst case soil identification, cycle development, clean /dirty hold times, etc.)

  • Support validation of cleaning/W&S equipment

Raw Materials and Media/Buffer Preparation:

  • Prepare risk assessments and gap analysis related to raw materials

  • Support manufacturing processes related to media preparation

  • Filtration validation (fit for use for process conditions, retention, binding, compatibility, etc.)

Compliance and Safety:

  • Work within the framework of the Manufacturing Technology Team (i.e.: respecting schedule, phase gates, decision processes, design review deadlines, team culture, communication, documents, etc.), with professionalism and transparency, and delivering in a timely manner in accordance with the design and execution schedule requirements

  • Ensure operating procedures are current and followed, and site and corporate policies are adhered to

  • Ensure the project is carried out in a safe manner and safety issues are effectively resolved

  • Supervises and monitors compliance with employment and health and safety legislation to ensure that employees work within the policies, procedures and regulations applicable to their work.

  • Participates in the investigation of incidents and work-related illnesses

  • Responds promptly to all health and safety concerns or incidents and completes the appropriate documentation in a timely manner

  • Takes every reasonable precaution to ensure the health and safety of staff

  • Ensures that protective equipment and clothing required is used by staff

  • Cooperates and assists the Joint Health and Safety Committee in carrying out its functions

  • Advises staff of any potential or actual health and safety hazard of which they are aware

Education/Experience:

  • Minimum B.Eng., B.Sc. or equivalent

  • 8+ years direct experience in pharma/biotech manufacturing, and quality environments/organizations in a process validation role

  • Experience in cleaning and critical materials process validation is a strong asset

  • 5+ years demonstrated leadership in behavioral competencies and management is required

Hours of Work:

Monday to Friday: 8:00 – 4:00 p.m.

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

#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.

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, Empowering Life