Director B200 Operations 

Reference No. R2834273

Position Title: Director B200 Operations 

Department: Manufacturing

Location: Toronto, ON

About the Job

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

Sanofi Vaccines

Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.

At Sanofi, we chase the miracles of science to improve people’s lives.  We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people. 

The Director B200 Operations is responsible for leadership of the operations team for a key strategic capital project. Accountable for operational oversight of design, construction, commissioning, validation, licensure and startup of the new influenza drug substance manufacturing facility and will be responsible to build and lead an organization to help develop and operate the new facility.  Implementing highly automated processes and completely digital industrialized manufacturing systems including full integration of automation and control systems, data historians, LIMS, ERP(SAP) and MES to revolutionize biologics manufacturing capabilities in the Sanofi network.  Lead key project and manufacturing initiatives for B200 to provide direction and strategic vision.

The Director B200 Operations will report directly to the Head of Drug Substance. The Director B200 Operations will build a team to support each phase of the project per the project approved operations staffing plan.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities:

Project strategy and execution

• Ensures that operations team, in conjunction with other organizational platforms, are successfully deliver project objectives and deliverables on time and in budget.

• Leader operations team to support design of process and facility through all stages of project (URS, DQ, IQ/OQ/PQ, Engineering runs).

• Lead key manufacturing initiatives for the B200 project to achieve project deliverables and ensure readiness for project activities and manufacturing start-up.

• Development and optimization of schedules to support validation, engineering runs and full scale manufacturing.

• Support the development of workforce planning and organizational structure to support project and manufacturing activities (upstream, downstream, MWS, etc) from design to start-up.

• Provide strategy and guidance for the development of manufacturing training and start up B200 operations.

• Engage operations team to be key player in execution of validation activities related to equipment and facilities.

• Monitors & communicates team performance to Project leader and core team

• Lead development of operating budget and staffing for operations and project related activities.

Innovation

• Directs the incorporation of new technology into manufacturing process in the new facility to reduce costs and to improve quality and delivery capability. 

Compliance & Quality

• Works with Quality functions to ensure compliance with GMP requirements.

• Lead team to develop and maintain operating procedures in adherence to global and site policies.

• Ensure compliance of facilities & equipment.

People and Development

• Attracts, motivates, develops and leads qualified staff in order to ensure the continuous improvements in manufacturing processes with attendant improvements in quality per unit cost, & delivery capability.

• Organizes and develops staff to ensure a high performing team; establishes, monitors and provides individual feedback on staff objectives; ensures training of staff according to training plans and to continue to develop their competencies; coach staff on personal development goals and document follow up.

• Contributes to the B200 project management team, communicates and co-operates with other departments to obtain consensus and ensure appropriate service levels.

• Hire new employees and follow company’s procedures; responsible for attendance management and time reporting system.

Continuous Improvement

• Implement and execute lean management systems established for Bulk; ensures continuous improvement processes; troubleshoot and lead resolution for manufacturing design and project initiatives.

• Provides metrics and other reports as requested.

Accountable for a safe workplace by supervising and monitoring compliance with employment and health & safety legislation to ensure

• That employees work within the policies, procedures and regulations including responding promptly to all health and safety concerns or incidents; critical incidents and accidents are reported to the appropriate authorities; potential safety and health hazards are identified and known by staff and that protective equipment and clothing are required and are used; continuous HSE awareness and improvement by integrating team with site and Bulk initiatives.

• Cooperation with and assistance to the HSE management and Joint Health and Safety Committee in carrying out their functions.

HSE REQUIREMENT/STATEMENT

• 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.

Major Challenges:

Building and leading operational project team to deliver flu vaccine production on time as per demanding project schedule while exceeding the increasing requirements for quality and safety requires a high degree of flexibility and creativity.  Supervision of operations through two levels of management. Decisions are made on highly complex matters involving large and long term commitments of resources.

Dimensions/scope:

• Team size: From 5 to 150 Staff evolving over course of project

• Oversees specific area of operations in Building 200

• Interact successfully within the highly energized production and regulatory environments.

• Drive continuous improvement for production, Industrial Performance, and Compliance.

• The incumbent must be able to communicate clearly the cGMP requirements.

• Responsibilities are dedicated to the manufacturing facility site location; however, intermittent travel to international company sites and to both domestic and international equipment manufacturers will be required.

• Partnership with 3rd party engineering and architectural firms awarded the facility design, construction and execution of the project will be required.  Travel to the 3rd party firm offices for project design may be required.

• Freedom to act, level of autonomy: Position has a high degree of autonomy and is expected to make decisions and interpretations regarding design, execution and personnel decisions in regard to her/his accountabilities. 

About You

Key Requirements:

• Bachelor degree in Science/Engineering/Business or in a related field.

• 6+ years of experience in Pharmaceutical/Biotech engineering or operations environment.

• Management experience is required.

• Effective communication skills along with thorough knowledge of cGMP and regulatory requirements.

• Project leadership experience which includes project planning, resource management, execution, and closure.

Travel maybe required within Canada or globally.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and well-being benefits including high-quality healthcare, prevention and wellness programs

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.

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