Aseptic Filling & Formulation Manager — 2nd Shift

Sanofi; Northern (KY); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

State-of-the-art facility

Startup leadership role

Career development

Job summary

Sanofi is seeking an Aseptic Filling and Formulation Manager to lead sterile production startup efforts in a state-of-the-art facility in Swiftwater, PA. This 2nd-shift leadership role oversees the transition from startup through qualification and into commercial readiness, ensuring GMP compliance and regulatory readiness.

You will drive media fills, PPQs, and digital initiatives while building a high-performing team capable of delivering complex qualification milestones and a scalable

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field; 1+ years GMP manufacturing ops experience and 6+ months leadership OR High School Diploma with 5+ years GMP manufacturing ops experience and 1+ year leadership
• Demonstrated experience in aseptic processing operations (Drug Substance, Drug Product, Biologics)
• Strong GMP knowledge and regulatory compliance understanding; excellent technical writing and communication skills

Responsibilities

• Lead startup operations for aseptic filling and formulation in a new facility through commissioning, qualification, and commercial readiness
• Drive Development Aseptic Process Simulations (media fills / APS) by Q4 2026
• Oversee PPQ execution and commercial readiness activities in 2027; ensure inspection readiness by December 2027
• Champion a digital-first approach using data analytics and digital tools to optimize performance

Skills

Leadership

GMP knowledge

Analytical thinking

Digital tools proficiency

Communication skills

Regulatory compliance knowledge

Education

Bachelor's degree in Life Sciences or Engineering

High School Diploma with 5+ years GMP experience

Tools

eOOE

iObeya

SAP

Qualipso

Ocularis

Data analytics tools

Job description

Sanofi is seeking an Aseptic Filling and Formulation Manager to lead sterile production startup efforts in a state-of-the-art facility in Swiftwater, PA. This 2nd-shift leadership role oversees the transition from startup through qualification and into commercial readiness, ensuring GMP compliance and regulatory readiness.

You will drive media fills, PPQs, and digital initiatives while building a high-performing team capable of delivering complex qualification milestones and a scalable