Sanofi Pasteur Inc.
B87 Filling and Formulation Manager
Swiftwater, PA · Junior
Sponsorship not specifiedDetected 2 days ago
Data AnalysisComplianceSAPProcess ImprovementGMPFDA RegulatoryLeadershipCommunicationCollaborationProblem SolvingCritical ThinkingMentoringWritingAdaptabilityLean Manufacturing
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odds of building a lasting career here
40Risky
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
Thin sponsorship signal and lottery-bound. A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
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About the role
- You are a hands-on, forward-thinking leader who brings deep GMP expertise, a digital-first mindset, and the courage to challenge conventional processes.
- Schedule Note: This role requires a flexible schedule during the startup and qualification phases, with a transition to an assigned shift (2nd or 3rd) during commercial operations.
- C&Q activities will predominantly occur on first shift; media fills, PPQs, and commercial launch activities will require shift-aligned hours as applicable.
Responsibilities
- A rare opportunity to build operations from the ground up in a state-of-the-art aseptic facility
- Join a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale.
- Lead startup operations for aseptic filling and formulation in a new facility environment, serving as the operational anchor through all phases of commissioning, qualification, and commercial readiness
- Drive preparation and execution of Development Aseptic Process Simulations (media fills / APS) by Q4 2026
- Champion a digital-first approach to operations, leveraging technology, data analytics, and digital tools to optimize performance and decision-making
- Challenge conventional processes and drive continuous improvement across the operation
- Build and develop a high-performing, agile team aligned with company values and culture
- Lead the operations team through all facility startup, commissioning, and qualification phases
- Drive execution of Environmental Monitoring Performance Qualifications (EMPQs)
- Lead Development Aseptic Process Simulations (media fills) beginning Q4 2026
Requirements
- Demonstrated experience in aseptic processing operations (Drug Substance, Drug Product, Biologics)
- Strong working knowledge of GMPs and regulatory compliance requirements
- Proven leadership experience with the ability to build, develop, and manage teams
- Proficiency with digital systems and data analytics tools
Nice to have
- Experience in facility or production line startup, commissioning, or qualification activities
- Background in media fill execution and aseptic process validation (APS/PPQ)
- People management experience with a demonstrated track record of hiring and developing a new team
- Knowledge of continuous improvement methodologies (Lean, Six Sigma, or equivalent)
- Experience with Lean manufacturing operating systems
- Familiarity with Industry 4.0 concepts and digital manufacturing tools
- Change management experience in a regulated manufacturing environment
- Ability to influence across functions and organizational levels without direct authority
Skills
- 2025-2026
- Startup & Qualification, Facility startup, C&Q activities, EMPQs, Smoke Studies, Media Fills
- Q1 2027
- Development Aseptic Process Simulations (APS)
- PPQ Execution, PPQ campaigns, inspection readiness, regulatory preparation
- Commercial Operations
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation - at speed and scale
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
- Intellectual Curiosity: Genuine desire to continuously learn, improve, and explore new approaches
- Critical Thinking: Strong analytical and problem-solving capabilities applied to complex qualification and operational challenges
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This listing is sourced directly from Sanofi Pasteur Inc.'s careers page and normalized into a canonical job model.