Aseptic Filling & Formulation Startup Lead

Sanofi; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Startup environment

Leadership role

Global network

Job summary

Sanofi is seeking an Aseptic Filling and Formulation Manager in a state-of-the-art facility in Swiftwater, PA. You will lead aseptic filling and formulation startup, manage media fills, and drive PPQ readiness with a digital-first mindset to enable a rapid path to commercial readiness.

You will guide a high-performing team through commissioning, qualification, and regulatory readiness, ensuring strict GMP adherence and cross-functional collaboration in a dynamic startup environment.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field with 1+ years of pharmaceutical/GMP manufacturing operations experience and 6+ months of people leadership experience (formal or demonstrated leadership capability) OR High School Diploma with 5+ years of pharmaceutical/GMP manufacturing operations experience and 1+ years of people leadership experience.

Responsibilities

• Lead startup operations for aseptic filling and formulation in a new facility environment, serving as the operational anchor through commissioning, qualification, and commercial readiness.
• Drive execution of Development Aseptic Process Simulations (media fills) by Q4 2026.
• Oversee PPQ execution and commercial readiness activities throughout 2027, ensuring inspection readiness by December 2027.
• Champion a digital-first approach to operations, leveraging data analytics and digital tools to optimize performance.

Job description

Sanofi is seeking an Aseptic Filling and Formulation Manager in a state-of-the-art facility in Swiftwater, PA. You will lead aseptic filling and formulation startup, manage media fills, and drive PPQ readiness with a digital-first mindset to enable a rapid path to commercial readiness.

You will guide a high-performing team through commissioning, qualification, and regulatory readiness, ensuring strict GMP adherence and cross-functional collaboration in a dynamic startup environment.