Job Description

Reference No. R2642313

Position Title: Operations Manager - Downstream

Department: Operations - Downstream

Location: Sanofi Pasteur Limited, Toronto

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.

Who You Are

You are a dynamic individual with a passion for public health. You believe in ensuring safe, high quality vaccines are accessible to all, and thus you have a desire to join the new Flu Building Project at the Toronto site. You have a proven track record of delivering on project milestones to ensure the success of a key project within challenging timelines, and have demonstrated the mindset of a trusted people leader.

Position Summary:

The Downstream Operations Manager reports directly to the Deputy Director - Downstream Processing, for Flu Vaccine manufacturing. This is a rapidly growing team responsible for the technology transfer and start-up of a high-profile global project.

Key Responsibilities:

Participate in the design, commissioning, startup, and troubleshooting of Downstream processes (Clarification, TFF, centrifugation, inactivation, final filtration, in-process testing) and equipment operations through all stages of project (C&Q, Engineering runs, PPQ, commercial operations).

Manage the procurement process and readiness of small equipment within Operations for engineering runs and start-up.

Review and approve technical and quality related documentation. (P&ID, IOQ, PPQ, and design documents).

Provide troubleshooting and problem-solving guidance for daily project and manufacturing issues, and implement preventative/corrective actions.

Participate and support the incorporation of digital technology (eg. electronic batch record and e-logbooks) into manufacturing process in the new facility to reduce costs and to improve quality and delivery capability.

Develop and execute production schedules from project through full scale manufacturing, ensure that project support and production activities are executed as per defined schedules.

Lead operations team execution on the shop floor for equipment, processes, and facilities. Monitor and communicate team and project performance with respect to deliverables using visible metrics.

Support development of operating budget and staffing for operations and project related activities from design to start-up.

In collaboration with the site Quality team, ensure compliance with GMP requirements, develop quality continuous improvement initiatives, develop staff in quality culture and GMP knowledge.

Ensure that all Operating Procedures, training plans, and manufacturing documentation are current, developed in adherence to global and site policies, and completed in a timely manner.

Support internal and external regulatory audits/inspections and coordinate appropriate responses.

Identify and lead initiatives to increase process efficiency, quality and/or yield. Implement solutions or changes via change control, plan and manage facility and organization improvements.

Supervises a team of 10-20 people in production and support activities throughout the progress of the project, and commercial operations.

Key Requirements:

Bachelor of Science Degree in Engineering or Scientific Discipline, and 5+ years of industry experience in a GMP environment.

Managing direct staff in a GMP environment.

Highly proficient in Word, Excel and PowerPoint.

SAP (preferred) or other Enterprise Resource Planning (ERP) system.

Experienced with Manufacturing Automation (eg. DeltaV) and electronic batch records will be an asset.

Ability to set priorities and act with appropriate sense of urgency.

Ability to collaborate with cross-functional peers, including change management, quality disciplines, and production management.

Must be able to work quickly with a high degree of accuracy. Must possess sound interpersonal and information gathering skills.

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.