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Manager Continuous Improvement - Vaccine

Swiftwater, Pennsylvania

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Overview

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  • Problem-Solver
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Culture: Play to Win

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    Collaboration

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

"Patients are at the center of our work. Our teams focus on advancing transformational therapies, and expanding patient access to our medicines."

Mouhamed Gueye US Head Medical, Rare Blood Disorders

Responsibilities

Summary of Purpose/Major Responsibilities:

This position takes a leadership role in identifying and resolving issues of safety, compliance, and efficiency that impact the supply of bulk Biologic vaccine products.  This position contributes as a member of cross-functional teams to support Biologics Manufacturing.  Each team may have representatives from M-Tech, GEM, Quality Assurance, Sterility Assurance, and Planning, requiring a high degree of relationship building, communication, technical knowledge and leadership.

Key Accountabilities:

  • Responsibilities include leading small/medium/large project scope and solution development, the use of statistical/lean/FMEA and other methods to performing preliminary options analysis, change control development and execution, commissioning and qualification documentation development and execution, project execution tracking and project completion activities.

  • Represent factory with internal and external suppliers and customers:  Support technical operational leaders with equipment vendors and material suppliers to ensure effective performance of Swiftwater operations.  With limited supervision, represent factory leadership and provide input and guidance to external projects.

  • Be a Subject Matter Expert (SME) on the state of the industry trends for Bulk Manufacturing. Through continuing education, remain current with industry knowledge, trends, and best practices. As a SME, provide strategic input required to stay competitive in the bulk vaccine manufacturing market.

  • Attend all L1 +QDCI board meetings to gather and report out on issues/opportunities existing on the shop floor.

  • Actively develop, promote, and implement safe work practices to ensure safe working conditions for all employees

Context of the Job/Major Challenges:

  • The Manager, Continuous Improvement will identify, investigate, gain consensus and resolve issues that impact the supply of Antigen products.  They will support projects and lead small projects to maximize the safety, quality, efficiency and effectiveness of the antigen factory.

  • The Manager, Continuous Improvement is tasked with leading change.  This position is a responsible interface between operations and support functions, and is expected to work effectively with partner functions such as Quality and Manufacturing Technology to ensure continuous improvement of the assigned factory.

  • The Manager, Continuous Improvement will provide operational input to the bulk antigen continuous improvement team by direct participation and integration into factory operations.  This is accomplished through a high degree of shop floor presence and participation with other functions in the focus factory as directed by the CI team leader.

  • The Manager, Continuous Improvement will serve as a scientific and technical interface with suppliers and customers of equipment and materials.

  • The Manager, Continuous Improvement will lead change controls, small process improvement initiatives, and other activities as assigned.  The Manager, Continuous Improvement will assist with deviation investigations and trouble-shooting of production equipment.

Basic Requirements:

Minimum 3-5 years experience in a cGMP role.

BS in Engineering, or similar technical field.

Preferred Qualifications:

The ideal candidate will possess a demonstrated history of successful project leadership including project planning, resource management, execution and closure; experience in the areas of customer support, operational excellence, and troubleshooting.  In addition, the candidate will possess process or automation knowledge of pharmaceutical equipment and processes, and technical knowledge in cGMP manufacturing

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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