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CMC Leader

Swiftwater, Pennsylvania

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Responsibilities

CMC Leader- Influenza Vaccines

Location

Swiftwater, PA OR Meriden, CT

Who You Are

You are a dynamic CMC leader interested in leading the CMC (Chemistry, Manufacturing and Control) team in the frame of the development, launch and early life cycle (up to 2 years) of new vaccines (NV), as part of the Global NV Project Team.

You are an agile and highly adaptative person seeking to work in a dynamic and multicultural environment.

You have a great sense of accountability, a solid technical background as well as strong leading competencies to ensure the success of the CMC activities, and ultimately of the new vaccine projects.

You navigate easily between high level strategies and detailed technical discussions; you are able to efficiently translate information back and forth between operations and senior leadership.

Who We Are

Within the Sanofi Pasteur Industrial Affairs, Manufacturing Technology (MTech) department’s mission is to deliver robust and efficient process with associated know how transfer to Manufacturing. Manufacturing Technology also provides daily support to manufacturing toward industrial performance excellence.

Within MTech, the CMC & LCM (Life Cycle Management) platform has the mission to support all the industrial CMC activities in the new vaccine’s projects portfolio, in interface with R&D and other functions. In collaboration with R&D, the platform also contributes to incorporate and continuously improve best-in-class best practices and standards in NV projects management. Finally, the platform manages the technical life cycle of licensed products, to support the development and implementation of sound industrial product strategies.

Where We Are

Swiftwater, PA

Located in Pennsylvania, 90 miles west of New York and less than 12 miles from the New Jersey border, in the beautiful Pocono Mountains, It has many outdoor activities for all families, like lakes, rivers, hiking trails, Ski Resorts, waterparks and is also located affordable North-eastern Pennsylvania with convenient highway access.

OR

Meriden, CT

Meriden is located at the Crossroads of Connecticut, being bisected by two of the State’s major freeways (I95 and (91), Meriden is situated midway between the cities of New Haven and Hartford, located about 20 miles to the north and south, respectively. Train service is available from the State St. station.  The City is located within 25 miles of several world-class educational institutions.

Job Highlights

  • Within the NV Project Team as Team Member
    • The CMC leader is accountable for CMC & Launch readiness activities in the Global NV project team, representing CMC, and contributing to the project strategy by bringing the CMC input and knowledge
    • Leads definition of the Quality Target Product Profile (QTPP) and gets it approved by the relevant committees
    • Is accountable for the definition and the endorsement of the CMC & launch readiness strategy by relevant committees and decision bodies, aligned with the project strategy and the QTPP
    • Is accountable for endorsement of the CMC & launch readiness plan that will allow proper CMC resource allocation and prioritization within functions
    • Is responsible for the quality of CMC requirements to deliver upon clinical and validation supplies (DS/DP), and CMC elements for regulatory submissions and consultations
    • Provides to the Global NV project team CMC strategy and CMC activity updates
    • Critically evaluates the function proposals in the Global NV project team and proactively provides scenarios for CMC alternatives/options and scenarios when needed
    • Leads the team to manage risks and opportunities that could potentially impact the project objectives and the CMC and launch readiness deliverables, and alert on time the Global NV project team
  • Within R&D and IA Functions as CMC Team leader
    • Leads the CMC project team (transversal management) and coordinates all CMC and launch readiness and post launch (up to 2 years) activities
    • Empowers CMC team members and contributes to their development (feedback, coaching, participation in strategic committees…).
    •  In alignment with Global NV project team objectives, works with CMC team members to define their annual CMC objectives and gets them endorsed by the functions
    • Leads the CMC team in order to get CMC & launch readiness strategy endorsed by steering committees.
    • Works proactively with CMC functions to optimize resource allocation proposals, milestones, timelines, cost…
    • Is responsible for timely (CMC milestones and deliverables) and quality implementation of the CMC strategy within budget (OPEX & CAPEX, internal resources & external costs)
    • Ensures proper Quality by Design implementation for the project
    • Drives evaluation of CMC & launch readiness risks by implementing the CMC risk management tools, manages risks/opportunities ensuring endorsement by the appropriate committee/function of a mitigation plan when necessary
    • Provides to the functions CMC strategy/activity/risks updates and risk mitigation activities
    • Timely alerts appropriate governance bodies and communicates information to stakeholders (i.e., be the key CMC contact person for the NV project)
    • Insures implementation of project best practices, definition of project charter and team members Roles and Responsibilities, project governance, project development plan and project reporting
    • Ensures proper communication and capitalization of lessons learned

Basic Qualifications: 

  • PhD, Master Science, Bachelors Science in one of the areas of Life Science or biological sciences.
  • 10 years’ expertise in CMC area (vaccines or biologics), with proven experience in at least 2 scientific areas (e.g., analytics, process development., regulatory CMC, manufacturing, etc.)
  • 5 years’ Analytical development experience
  • 5 years’ experience in project management and leadership, in working in project team and in complex environment (e.g., transversal assignments across different sites and different functions)
  • 3 years’ experience and understanding of current Pharmaceutical environment including the economic, technical and regulatory challenges

Preferred Qualifications: 

  • 1 year experience in leading international and/or multi-cultural teams

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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