Project Leader, Recombinant Flu Project
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our Sanofi Pasteur Swiftwater, PA site, where we both research and manufacture vaccines since 1897, has had a tremendous impact on global health and the quality of human life. Nestled among the Pocono Mountains in Swiftwater, Pennsylvania, Sanofi Pasteur is home to state-of-the-industry facilities—and a rich and unique history. Our Swiftwater campus is more than 500 acres, housing 44 buildings and encompassing more than one million square feet of building space. Many of our facilities, while bright and modern, still retain the rustic charm of the original stonework.
Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."C. Richard Cioci Clinical Science Associate – Pompe Ontario East & Atlantic
"I am continually impressed at the dedication that Sanofi has to the patients for whom we provide solutions."Suncére Hernandez Area Business Manager, Multiple Sclerosis
"I give thanks to my powerhouse team for reminding me that I have a support system behind me, pushing me forward."Bob Shustack Head of Global Support Functions Finance, North America
Summary of purpose/major responsibilities
In accordance with Sanofi Pasteur’s strategy and priorities, lead and manage the end to end Recombinant Project for the Swiftwater, USA site from Conceptual 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.
- Lead the execution of the Recombinant Flu manufacturing facility retrofit project during all phases of engineering, validation and license (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, Manufacturing 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/USG contract.
Context of the job/major challenges
Highlight the most significant aspects of the environment that affects the job. Describe the most important problems to resolve to achieve the job’s major purpose.
- Provide leadership to the project team to achieve project objectives.
- Balance customer and project requirements
- Managing multiple stakeholders and project team functions often with competing priorities.
- Negotiating paths forward with various work streams.
- Maintaining strategic focus in a dynamic, ever changing tactical environment.
- Maintaining solid personal relationships in potentially challenging and adversarial situations.
Important problems to resolve to achieve the job’s major purpose
- Meet project commitments
Provide numerical data, if available, to describe the size of the job, or its impact on the business. Use annual figures and specify currency. Figures should include budgetary responsibility, purchasing authority, resources available. Highlight the key decisions made in this job. Outline the sphere of the job, such as whether the accountability are global, country specific, or function specific.
The scope of this project is retrofitting of existing facilities for seed and drug substance as under:
- Molecular Bio Strain construct
- Cell Bank & Working Seed production, Drug Substance production.
- This is a Tier 1 large GMP major project with estimated total project cost of ~$150 Million Compliance with Swiftwater site, Sanofi Pasteur, and Sanofi Group project management standards.
• 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
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.
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.
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