Startup Aseptic Fill & Formulation Manager
Sanofi
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Benefits offered by this job
Job summary
Sanofi is launching a state-of-the-art aseptic facility in Swiftwater, PA. The Production Manager - B87 Aseptic Filling & Formulation will lead startup operations through commissioning, qualification, and readiness for commercial manufacturing.
This role requires hands-on leadership, deep GMP expertise, and a digital-first mindset to optimize performance and regulatory readiness. The successful candidate will drive Development Aseptic Process Simulations (media fills) by late 2026 and oversee
Qualifications
- Bachelor's degree in Life Sciences, Engineering, or related field with GMP manufacturing experience
- Experience in aseptic processing operations (Drug Substance/Product)
- Strong GMP knowledge and regulatory compliance experience
- Proven leadership in building and managing teams
Responsibilities
- Lead startup operations for aseptic filling and formulation in a new facility
- Drive Development Aseptic Process Simulations (media fills) by Q4 2026
- Oversee PPQ execution and commercial readiness activities in 2027
- Champion a digital-first approach using data analytics and digital tools
- Build and develop a high-performing, agile team and ensure regulatory readiness
Skills
Education
Tools
Job description
Sanofi is launching a state-of-the-art aseptic facility in Swiftwater, PA. The Production Manager - B87 Aseptic Filling & Formulation will lead startup operations through commissioning, qualification, and readiness for commercial manufacturing.
This role requires hands-on leadership, deep GMP expertise, and a digital-first mindset to optimize performance and regulatory readiness. The successful candidate will drive Development Aseptic Process Simulations (media fills) by late 2026 and oversee
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