Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden

Reference No. R2795527

Position Title: Manager, FF&P Process and Project

Department:APU FF&P

Location: Toronto, ON (Hybrid)

About You

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. 

The Manager, Process and Projects is responsible for delivering on the current and future project needs and technical process support of the FFP APU Manufacturing Platform.  The FFP APU manufacturing platform includes B92 Media, Washing and Sterilizing, Formulations and B83 Filling, Inspection, Labelling and Packaging.  Future support to B53 Formulation and Filling.

The Manager, Process and Projects works with peers in the FFP APU to define projects that address complex HSE, Quality, Reliability and Productivity opportunities, following established project management processes at the site.  Combining an understanding of biologics manufacturing, cGMPS, and project management expertise, the incumbent is responsible for delivery FFP projects, including planning, execution and authoring change controls and quality documents in the required timeframes and budget.

The Manager will provide expertise, knowledge and skills on operational topics including investigations, impact assessments, technical papers, process troubleshooting, validation and statistical review of critical parameters.  Reports to Head of FFP APU.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

Work with FF&P APU and APT Leaders to develop and Prioritize Platform Projects

• Evaluate and define project feasibility, scope, timelines and quality, safety and operational requirements to address platform needs.

• Partner with the area SMEs and functional APU and APT representatives to find efficient and achievable solutions.

• Align stakeholders and supporting functions to the initiative, required support and expectations

• Follow Site Processes as required to get project approved and launched.

Execute Projects/Continuous Improvement within the APU

• Will lead or support projects depending on the size and scope in the capacity of an End to End (E2E) Project Leader, Manufacturing Workstream Leader, Subject Matter Expert and/or Support Resource.

• A multi–Project Portfolio will include predominantly Compliance, Safety, Productivity, Capacity, Gap and Risk Remediation, and Regulatory and CAPA commitments.

• Develop and lead key Change Controls to ensure timely execution and compliance.

• Author Quality Documents including URS, Quality Plans, VMPs and applicable SOPs.

• Manage Permanent and Contingent Manufacturing Resources Assigned to Projects as required.

• Lead Lean and Continuous Improvement Initiatives with emphasis on cost saving initiatives.

APU Representative on Project Matters and Project Sub-Portfolio

• Collaborate with PMO to ensure alignment of the APU with project, portfolio, risk processes and Site Strategy

• Coordinate the APU Steering Committee Meetings

• Facilitate new projects, evaluation of drivers and scope, and endorsement (in-take committee)

• Manager, maintain and prioritize the APU Project Portfolio in alignment with Site Portfolio Management

• Manage interconnection and linkages between portfolio projects and escalate risks or gaps

• Monitoring health of APU portfolio through KPI dashboard reviews and escalate conflicts or delays

• Risk Management SPOC – engage in process for risk assessment, evaluation and mitigation (identify and escalate risks to manufacturing process/capacity)

• Represent the FFP APU platform for relevant site wide initiatives

Work with APU and APT members to provide Process Knowledge/Expertise/ Deviation support

• Develop, implement and support knowledge transfer within APU as part of project execution.

• Provide technical support to quality and manufacturing as per priorities within the APU including regulatory commitments, failure investigations and process improvements.

• Support troubleshooting of manufacturing equipment and processes.

• Support and Execute Validation Activities including protocols and reports within Platform.

• Author and review technical reports and protocols.

Process Improvements and Manufacturing Capacity support

• Identify and escalate risks to manufacturing process/capacity.

• Lead with the Maintenance & Reliability team to build and maintain a robust and up to date PM plan for equipment to prevent equipment breakdowns and production delays.

• Lead Lean and Continuous Improvement Initiatives.

• Identify and escalate opportunities for cost saving initiatives

About You

Qualifications:

• ​Honors Degree in Related Science or Engineering Preferred

• Minimum 3-5 years in Commercial Manufacturing and/or Quality

• Preferred:  Minimum 3-5 years' experience managing projects in Biopharmaceutical and/or manufacturing environments

• Must possess great communication, organization skills and ability to self-manage while working multi-department team

• Good knowledge of cGMP in pharmaceuticals/biologicals

• Experience in project management, quality systems and quality risk management

• Good problem-solving skills, willingness to constantly learn new things and excellent documentation skills.

Optional: HSE requirements (mandatory if manufacturing site)

• 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

• Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.

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 wellbeing benefits including high-quality healthcare, prevention and wellness programs

This position is for a current vacant role that we are actively hiring for.

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise. Des informations supplémentaires sur les avantages sociaux peuvent être trouvées ici.