Sanofi Group Program Lead-New Product Introduction in Framingham, Massachusetts
*Monday-Friday- 1st shift*
*No direct report-to's*
Reporting directly to the Head of New Product Introduction at Framingham Biologics, the position provides leadership and direction to the investment and operations and new product introduction teams. The NPI Lead will be responsible to coordinate the design and execution of a projects to modify and augment the capabilities of 8NYA in accordance with a new Facility and Operational Requirements defined for the program. The NPI Lead is responsible and accountable for delivering the agreed project scope while adhering to time, cost, safety, and quality expectations.
Responsible for implementation, qualification, startup and licensure of the facility, whilst operating, safely, compliantly, and within the approved budget.
Overall responsibility for realizing the scope and objectives set by the business case including; Coordination of design between the sending unit and receiving unit, procurement, construction and operational readiness of the facility.
Ensures the program is executed in a safe, responsible manner working closely with Sanofi HSE safety programs and ensuring that that good behaviors are adopted and maintained through the program lifecycle.
Provides overall leadership of the program, with responsibility for the successful delivery of cGMP facility that is operationally ready for commercial production.
Responsible for managing a matrixed cross-functional team and providing the leadership required to ensure the team is successful.
Builds trust and confidence in the program and projects, addressing issues and concerns, managing differences and conflicts.
Monitoring metrics to ensure progress towards project goals, identifying and addressing systemic issues affecting execution, coordinating responses to events affecting safety, quality, schedule and cost.
Providing summary reports of overall cost & schedule status and projects.
Responsible for chairing Project Governance Committees and escalating any decisions or impacts to budget schedule or scope.
Responsible for working with the Quality lead to ensure that the design is compliance with all standards and regulatory expectations and for evaluating and approving any changes arising which could have a Quality impact.
Manages stakeholder and governance interfaces to ensure objectives are aligned, understood and well communicated. This includes the Program Sponsor, Steering Committee, Site SLT and Program Team.
Review risks, associated mitigation, and opportunities related to Project Execution
Prepares deliverables required to obtain approval and funding and authorizes expenditures for goods and services, including contractor, supplier and consultant selection within the approved scope of the project.
Interfaces with Process Development, Analytical and Technology Transfer Teams to ensure continuity between the sending and receiving units and operational readiness for successful tech transfer.
Bachelor's Degree in Engineering with 15+ years of experience in pharmaceuticals or similar regulated industry OR Master's Degree with 10+ years of experience
5 plus years' specific technical Project/Program management experience in a pharmaceutical or biotech organization
Significant knowledge and experience with major Capital Projects in a cGMP environment.
Clear technical experience in design and operation of bio-processing technologies.
Demonstrated understanding of capital project execution, biologics process development, scale-up and validation.
Experienced in technical transfer of pharmaceutical and biotechnology processes and bio-manufacturing at the commercial and/or pilot scale.
In depth knowledge of biotechnology process engineering and technology development and tech transfers and their practice in a commercial manufacturing
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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.