Title : Director – Program Leader MTEC Reference No : R2582344 Location : Toronto, Ontario 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. SUMMARY OF PURPOSE/MAJOR RESPONSIBILITIES Is the primary responsible within the Manufacturing Technologies department to lead the Industrialization of New products Responsible for managing a group of related projects in a coordinated way to facilitate a level of management and control that is not available from managing the projects individually Responsible for providing overall management and guidance to the projects running within the program. In particular, the correct sequencing of the various projects and allocation of resources for purposes of coordinating the achievement of deliverables is key to successful program management Able to see big picture and plan broadly; able to analyze and dissect complex situations and problems, identify technical risks and business risks, and lead the teams in constructively seeking options. Excellent communication skills, able to manage effectively multiple level communications up to top management and down to project team members, able to manage cross-sites and cross-functional communications Drive decision making capability within the program scope. Is able to present proposals effectively to senior management and direct escalation of project issues to sponsors per established governance Promote efficiency gains and improved working methods throughout life of the project Drive technology innovation and implementation within the project KEY ACCOUNTABILITIES Process Development Strategy Lead processes development (including comparability) for the new facility and to execute all operations related activities throughout the project life cycle. Establish the technical transfer strategy at optimized cost Develop efficient process (COG’s, volume, Quality, sustainability) Ensure that studies are based on scientifically sound principles. Review project strategies and tactics and/or obtain input from subject matter experts Responsible for program estimations, budgets, resources, major deliverables, quality of deliverables, gate reviews and maintaining project timelines. Ensure capacity requirements and resources are balanced, and align with functional, cross-functional and platform constraints. Responsible for program reporting to various governance at executive level. Support and lead engineering phases of the project (design, engineering, construction, licensure). Lead specific phases of the project (validation, start-up, ramp-up) in coordination with Operations. Support and lead a smooth transition from project execution, project batch manufacturing, licensure, and licensed manufacturing facility start-up and beyond. The MTech leader has decision making authority as the operations representative in the functional area (Manufacturing Technology) of the facility under their direct supervision and will be the Manufacturing Technology approver on associated documentation. The Leads are expected to maintain appropriate chain of communication and command within both the Sanofi and contracted support team members (EPCM team) to assure the project team retains the required discipline for successful execution. They will support project-related travel for key meetings, inspections, tests, etc. Staff Development: Establish, staff, develop, and lead multi-discipline & cross-functional program organization Build and lead an organization to help develop their respective parts of the new facility and to execute all operations related activities throughout the project life cycle. Develop next generation of leaders and build a competent support team (Manufacturing Assistance). Manage project leaders to develop strategies and plan activities related to individual project. Manage MTEC team members and participate when appropriate in project teams, working groups and task forces (local and or global). Responsible for scientific and technical aspects of the assigned program. Understand and support the strategic vision on the future of the company both technically and commercially. Interact with cross functional teams Production, Quality Operations, Regulatory and other internal and external groups (France and USA) to support process and technology transfer, scale-up, process improvement and validation. Manage interfaces and ensures clear communication between projects, Site Leadership Team, Global Functions, and Executive Leaders Share knowledge and area of expertise to support projects and stay abreast of current advances in area of technical expertise by developing a strong connection with the MTEC Knowledge and Innovation Lead Interact closely with the MTEC Projects Excellence Office to increase efficiency in scope, time, cost, and risk management Act as a delegate for MTEC site Head 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 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 CONTEXT OF THE JOB/MAJOR CHALLENGES The Toronto site has entered an exciting period of unprecedented projects volume. The Program leader at Sanofi Pasteur (SP) Industrial Affairs is tasked with designing a program strategy and delivering a series of eclectic projects that will enable future operations Manufacturing Technologies (MTEC) Toronto has designed a new organization structure in order to increase products and processes knowledge in operations. As a result of this organizational evolution, a MTEC Program Lead role is created This role has accountability for overseeing the deliverables related to the projects. Due to the critical nature of the activities performed throughout the projects, this is a high-pressure position as the program leads are dealing with many different functions both at the local and global levels. It is important that the incumbent works well transversally and is able to get alignment on topics. The incumbent must be able to make decisions in a high paced environment. The incumbent must be flexible and willing to drive change across the organization This role is critical to sustain production demand for commercialization of products (planned in 2026) DIMENSIONS/SCOPE Breadth of responsibility (global/regional/country/site): coordinate inter-site project activities (Global), coordinate activities cross-functionally (Local), accountable for multiple products/processes within programs; Eggs handling, Production Processes (Inoculation, Harvest, Purification, Inactivation), Cleaning Validation and Single Used Technologies are the major projects/workstreams in scope Resources Management varies on program scope: 6-10 N-1 (Median range) Indirect management of cross-functional team: up to 50 members Budget Management: Opex =$15m & Capex ==$50m (Median range) # of projects 5 – 10 Manage broad range of roles: Technologist, Managers (Level 2) to Deputy Directors (Level 3) Manage experts (Bioengineers, Pharmacists, Doctorates and Post-Doctorates) This position applies managerial & technical leadership to ensure successful end-to-end execution of programs. Interconnected projects may range from process improvement in strains, buffers manufacturing, eggs inoculation, centrifugation, clarification, micro-filtration, adsorption, formulation, filling to support business needs. Autonomy in the way to drive Programs and related complex stakeholders’ requirements as programs may contain operations or "other work" for only for a finite period when some deliverables need to be supported and run, while other projects are still working on other aspects of the final solution. REQUIREMENTS Education/Certifications: Minimum Bachelors, Masters, or PhD in basic sciences with minimum 15 years related experience. Experience: >15 years direct experience in biotechnology manufacturing People management to lead Process and Manufacturing Sciences (> 15-20 persons) Demonstrated technical competences in biopharma or life science industry Demonstrated Industrial accounting and business acumen Drive continuous improvement programs Key technical competencies: In-depth experience in vaccines process development and industrialization Facility design start -up with cross-functions management, Vaccines Bulks Technical transfer exposure Design and project conceptualization for drugs as per FDA and EMA regulatory guidelines. Expertise in process development, Drug substance development, scale -up and scale -down model design for integrated upstream, downstream and analytics to support manufacturing process optimization and facility throughput. Late stage development to support CMC regulatory filings, experience in filing IND, (USFDA), and IMPD (EMA). Has technical experience making it possible to identify critical information and understand its impact on projects and programs outputs Able to challenge the experts in a constructive way to improve products and processes knowledge (SPP, subject matter experts…) Proficient in Project and Programs leadership and methodology, including budgeting, cost/benefit analysis, process design, process validation and change management Project and Program Management (Tools & Methodology, PM certification), Risk assessment (FMEA, FTA, HAZOP, etc.) and mitigation at all stages of process development and manufacturing Statistical Process Control (SPC) skills and Six Sigma methodology Soft skills: communicate transversally at all levels of the organization, negotiation, conflict resolution, facilitation, team motivation, empowerment, critical thinking, emotional Intelligence, creative problem solving, organizational change management, think strategically, make decisions Strong leadership with experiences in network or functional management Effective communication skills, including negotiation, conflict resolution, emotional intelligence; critical thinking and problem solving Cooperate transversally; strive for results, commitment to customers, lead teams, Act for change 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 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.