CMC Project Operations Manager-Swiftwater, PA
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
The primary purpose of the Project Operations Manager (POM) in CMC and Tech Transfer (TT) environment is to manage the CMC activities in R&D and IA reflecting the overall CMC strategy and/or Tech Transfer activities reflecting the Tech Transfer strategy .
He/She is responsible for the monitoring and follow-up tracking of the operational project progress. The POM is member of project team and coordinating teams/sub-teams and provides proactively optimization of cross-functional operational activities.
The POM reports to the Head of Excellence Platform for CMC/LCM/TT.
In alignment with department best practices, he/she is responsible for the preparation of decisions around service agreements, timing, resources and costs with the CMC / TT Project Leader and enables the selection of the best strategy through delivery of scenarios. He/She ensures the operating project team support.
- Provides the Project Leaders (PL) with high quality project plans on timelines, costs and resources using SHINE solution with integrated risk management, reflecting the selected strategy for projects in development/industrialization/ launch and post launch/LCM/ Tech Transfer;
e.g. develops and creates integrated detailed operational project plans, analyzes and monitors the project timelines, impact of risks, resources and costs (investments)
- Analyses the project plan and timelines along the product value chain and ensures optimal critical path
- Develops scenarios from project need phase, elaborates first cost/timelines estimate and up to the end of the project provides recommendation for optimization
- Ensures the collaboration with all the planners from the project involved platforms or the enabling functions to guarantee consistency between the project plan and the operational plan
- Monitors the progress, deviations with their explanation and the impact on the associated action plan
- Assures proactively regular consolidated updates/reporting to all project stakeholders
- Participates to the enhancement of the MTech Project Management tools and Excellence best practices
- Support Work-stream Leaders and Work-stream Team Members to enhance performance on any subject activities required to deliver the objectives
- Facilitate Lean workshop to enhance performance
Management & Expertise
- Defines, challenges, consolidates and controls costs and resources from all functions involved on the project and is the key person on the consolidated project costs and resource related questions
- Translates and visualizes the project strategy into an operational plan and ensures the optimal critical path
- Stakeholder management information that activities are on the critical path (e.g for submission, launch readiness, etc.)
- Proposes and establishes definitions of key parameters, key milestones to facilitate the monitoring of development and transfer activities
- Develops a customer focused reporting to the Project Leaders and stakeholders
- Shows autonomous attention handling of tasks and topics, that have been delegated by the Project Leader(s) (PL)
- Leads operational meetings, minute-taking, elaborating an action plan and follow-up on actions
- Is in charge of communication/information sharing platforms (e.g. e-rooms, share points)
- Is a day to day interface management with people from functions and departments involved along the value chain takes place by the department associates; and enabling functions on a global level and across different cultures
- A Masters of Science or PharmD, degree required
- Minimum 5 years of Project Management Experience, preferably within the area of drug /vaccine development in the biotech and/or pharmaceutical industry
- Experience in using databases and Project Management tools: (e.g. MS Project, Gantt Chart, Excel, etc.)
Specific experience and knowledge:
- Knowledge in CMC activities and requirements (industrial development and manufacturing to launch readiness)
- Well-developed communication and negotiation skills to work in non-hierarchical, international, multi-functional teams of skilled experts
- Successful experiences in managing projects and being familiar with project management tools
- Good knowledge of risk management (identification, evaluation, mitigation) and understand of any impact on deliverables
- Good knowledge in the regulatory guidelines related to requirements, quality and change control
- Excellent analyzing skills to understand and transform project activities, deliverables and milestones into a database structure.
- High capability to work result and quality oriented: to analyze results from all involved departments/platforms, to identify the impact, draw conclusions and propose steps for implementation.
- Presentation skills
- Language: English: very good skills in reading, writing and speaking required
- Good Microsoft office packages literacy and ability to understand various computer software and data bases
- Good networking skills in cross-cultural environment
- High willingness and ability to become acquainted with new fields (e.g. Vaccine Development, Industrialization, Launch Readiness)
- Customer focused
- Ability to cooperate transversally with many partners from different part and level of the organization
- Strong analytical skills, able to bring complicated topics down to the key points
- Conflict-resolution, negotiation- and decision-making skills
- Influence and persuasion skills
- Output oriented with pragmatic approach to new process implementation and problem solving
- High ability in change management
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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