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Manager Business Systems

Swiftwater, Pennsylvania

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Overview

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.

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Benefits

  • Health & Wellness

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • Financial

    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

  • Culture

    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.

  • Work/Life Balance

    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.

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Quote

"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

Responsibilities

Summary:

This role functions as the business systems interface between Biologics Manufacturing and various support functions on site, including but not limited to, Batch Release, Quality Systems, QC, Master Data, MDG Labware, FFIP, Planning, Procurement, Regulatory and Finance.

Responsibilities:

  • The position is responsible for ensuring focus factory lot release to align with the delivery commitments and production plans set in budget in order to meet all commercial and non-commercial supply demands.
  • Responsible for lot release and Formulation Schedule readiness for all manufacturing products.
  • Responsible for reviewing and approving all recipes creations and/or updates in SAP and Labware for all Biologics products.  This includes all commercial and project work for the platform including but not limited to commercial production, new buildings, and project work.
  • Responsible for oversight of all ROW (Rest of world) and International sample management for all commercial and project Regulatory commitments.  Cooperate transversally with Regulatory department to ensure all testing requirements needed by governing agencies are satisfied. 
  • Participates in developing and maintaining focus factory capacity assessments for areas including but not limited to freezer space for intermediate finished concentrate, container availability and movement for further processing for FFIP.
  • Responsible for creating and updating performance metrics for manufacturing, and driving action as needed. 
  • Provide support for various initiatives on site which includes support for Mtech projects, and projects ongoing by the Continuous improvement teams.
  • Provide SAP expertise to factory.  Responsible for the training and development of new personnel.  Collaborate with Manufacturing Excellence and Master Data groups to ensure recipes are accurate and functional for manufacturing. 
  • Work with various areas in submitting requests and document preparation of independent demands required for deviation investigations, Continuous improvement and MTECH projects, and additional testing as needed.  Responsible for AFFM of Biologic intermediates for further manufacturing without official release and the management of the business risks.
  • Core product team and tactical team member responsible for antigen lot release schedule creation, tracking and updates to ensure concentrate moves through the appropriate systems from start to release in time to meet the formulation schedule. 
  • Responsible for working with FFIP, materials management, planning, Batch release, QC, PQMR, and quality systems (QA and Deviation team) to ensure schedule adherence is met.  Provide support and troubleshooting as needed.  Includes ensuring all lots have authorized test results, closed deviations and CCR’s, and there are no outstanding unreleased materials used in production.  Collaborate with planning, production floor, and QC to ensure sampling and testing is completed in recommended time frame for formulation. 
  • Responsible for creation, management, and report out of various metrics for biologics manufacturing.   Includes performance metrics that monitor yields, concentrate readiness, and production document cycle time.  Take action as needed on items below established targets.
  • Provide support during all start up activities, document preparation, new material commodity and recipe requests, recipe updates, master specification tracking, general scheduling questions, SAP support, labware support, troubleshooting, additional sampling requests, etc. Responsible for the training and development of new personnel.
  • Interface with various project teams on site, such as Continuous Improvement,  MTECH, and other site initiatives.  Act as liaison between project teams and business systems group, production floor, master data, QC, planning, and batch release.
  • Responsible for oversight of all ROW (Rest of world) and International sample management for all commercial and project Regulatory commitments.  Cooperate transversally with Regulatory department to ensure all testing requirements needed by governing agencies are satisfied.  Collaborate with Regulatory and materials management department to ensure all testing required by governing agencies are satisfied.  Responsible for management of the expansion into the International markets for all Biologics products and the International complexities and variations required by individual countries.
  • Liaison between operations planning and the manufacturing focus factory shop floor as single point of contact for all production activities relating to that focus factory. Leads teams and projects as needed to support the manufacturing goals of the site.  Prepare and communicate focus factory activities in support of the Master Production Schedule.  Ensure 12 weeks production schedules are attainable. Ensure all raw materials are available to support the short term production schedule.  Prepares execution schedules to meet the delivery plans and includes any EM, Validation, APS plans into the 12 week schedule.  Includes CM01/Process order management.  Responsible for prioritization of manufacturing schedules to meet the promised delivery dates. This includes all execution activities related to delivery from schedule to release of the product.  Change controls, incidents, testing, production and batch release activities are tracked and followed up on.
  • Cooperate transversally with various departments on site for all biologics lot related information.  Responsible for the selection of lots and scheduling with both planning and the production area to ensure international requirements are met.  Provide guidance to finance in regards to POV, MDOs and IPDNs  and provide general support to planning and QC for lot scheduling. Interface with PQMR, procurement, and batch release to ensure materials are available and released for production. Responsible for AFFM of Biologic intermediates for further manufacturing without official release and the management of the business risks.

Basic Qualifications:

BS or BA degree is required.

2-4 years’ industry experience, preferred.

Demonstrated knowledge of MRP Systems, scheduling, and data analysis, excel, oral presentation skills.

Certifications

APICS/CPIM knowledge/certification preferred but not required

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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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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