Aseptic Filling & Formulation Startup Leader

Biopharma Careers

Swiftwater (MS)

On-site

USD 90,000 - 130,000

Full time

7 days ago

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Job summary

Sanofi is seeking an Aseptic Filling and Formulation Manager in Swiftwater, PA to lead aseptic filling and formulation operations during startup and qualification phases. You will oversee GMP compliance, drive media fills, and oversee PPQ execution toward commercial readiness, with a flexible startup schedule and shift-aligned duties during commercialization.

The role requires a hands-on leader with GMP expertise and a digital-first mindset to optimize performance, develop the team, and ensure

Qualifications

Bachelor's degree in Life Sciences, Engineering, or a related field with 1+ years of pharmaceutical/GMP manufacturing operations experience and 6+ months of people leadership experience.
Demonstrated experience in aseptic processing operations (Drug Substance, Drug Product, Biologics).
Strong GMP knowledge and regulatory compliance; ability to lead teams and drive startup/qualification activities.

Responsibilities

Lead startup operations for aseptic filling and formulation in a new facility environment through commissioning, qualification, and commercial readiness.
Drive Development Aseptic Process Simulations (APS) and media fills by Q4 2026.
Oversee PPQ execution and commercial readiness activities in 2027; ensure inspection readiness by December 2027.
Lead cross-functional collaboration and maintain GMP compliance and regulatory readiness.

Education

Bachelor's degree in Life Sciences, Engineering, or a related field with 1+ years of pharmaceutical/GMP manufacturing operations experience and 6+ months of people leadership experience