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Sanofi Group Project Leader, Pandemic FFIP Project - Vaccine in Swiftwater, Pennsylvania

The Work You Will Do:

The Project Leader in accordance with Sanofi Pasteur’s strategy and priorities, lead and manage the end to end Pandemic Flu Form, Fill Finish Project for the Swiftwater, USA site from feasibility engineering to commercial production ramp up. Accountable for successful project delivery on time, within Budget and in full compliance with the international regulations and Sanofi Policies. In full alignment and consistency with the Project Management Policies.

Where We Are:

The Swiftwater site is located in the beautiful and affordable Pocono Mountains of Northeastern Pennsylvania. Our site is Sanofi Pasteur’s US headquarters shared by Commercial Operations, R&D, Regulatory Affairs and the Industrial Operation teams and located 90 miles west of New York and less than 12 miles from the New Jersey Border with convenient highway access. The Swiftwater site is vast at over 500 acres and consists of 40 buildings and 14 modular buildings, housing more than 3,000 employees, including nearly 1,850 employees in Industrial Operations.

Job Highlights:

  • Lead the execution of the Pandemic Flu Form, Fill Finish Project during all phases of engineering, validation and licensure (up to ready for commercial operations) in accordance with safety, quality, performance, cost and Schedule objectives of the project.

  • E2E Project leader may be assigned additional tasks/projects based on the work load and spacing of project activities.

  • Ensure project governance and decision making route agreed upon, communicated, and respected by all project stake holders.

  • Ensure the projects resources availability for the different project steps, with strong focus on resource articulation between Global engineering and Maintenance (GEM), Site Technical Services, M. Technology, Quality Operations, Biologics Operations, HR, Regulatory Affairs, ITS, and Procurement.

  • Support the implementation of the regulatory strategy.

  • Ensure the raw material availability for all consumables for validation, start-up, and readiness for commercial production.

  • Ensure timely issue/conflict resolution, enabling project work stream leaders to meet project commitments.

  • Ensure that a risk management approach is defined and maintained up-dated all along the project stages; define and deploy the corresponding mitigation plan.

  • Lead and clear project stage gates in accordance with SWR/VIA project management process.

  • Promote production efficiency and investment costs optimization.

  • Work with Program leader to represent and interact with external agencies –USG, Vendors, SP global functions.

  • Accountable for project reporting as defined by Sanofi processes/BARDA contract.

Scope:

  • The scope of this project includes evaluation of CMO and Pandemic Flu Form, Fill Finish facilities within Swiftwater Site.

  • This is a Tier 1 large GMP project with estimated Total project cost >$150 Million.

  • Compliance with Swiftwater site, Sanofi Pasteur, and Sanofi Group project management standards.

Basic Qualifications:

  • BS/BA in Engineering or Biological Sciences (or other technical degree) required.

  • 10+ years’ experience working in biological or aseptic filling, operations, or technology role.

  • 5+ years’ experience leading projects or cross-functional teams in life sciences, biotechnology, or pharmaceutical company.

Preferred Qualifications:

  • Leading large project teams.

  • Interacting with external/global stake holders.

  • Interpersonal skills to resolve , escalate issues, manage risks.

  • Financial and technical understanding to help the team to meet objectives, prepare reports and be a good communicator.

Terms Of Employment :

Approximately 10% travel

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.

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