2nd-Shift Aseptic Filling & Formulation Leader — Startup

Sanofi; Swiftwater (Monroe County); On-site; USD 160,000 - 210,000; Full time

Job summary

Sanofi is seeking an Aseptic Filling and Formulation Manager in Swiftwater, PA, leading operations in a new facility through startup and qualification phases with a 2nd shift focus. You will drive media fills, PPQs, and ensure regulatory readiness, while championing a digital-first, high-performance culture.

You will oversee cross-functional teams, implement innovative solutions, and guide the operation toward commercial readiness by 2028.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field.
• 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.
• Excellent technical writing, communication, and interpersonal skills.
• Ability to work flexible hours, including extended shifts and weekends, to support qualification activities and production schedules.
• Proficiency with digital systems and data analytics tools.

Responsibilities

• 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.
• Oversee PPQ execution and commercial readiness activities throughout 2027, ensuring inspection readiness by December 2027.
• Apply innovative, analytically driven solutions to complex startup and qualification challenges.
• 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.
• Ensure strict GMP compliance and regulatory readiness at all times.

Skills

Leadership

GMP knowledge

Data analysis

Regulatory compliance

Education

Bachelor's degree in Life Sciences, Engineering, or related

High School Diploma with 5+ years GMP experience

Tools

SAP

Qualipso

Ocularis

iObeya

Job description

Sanofi is seeking an Aseptic Filling and Formulation Manager in Swiftwater, PA, leading operations in a new facility through startup and qualification phases with a 2nd shift focus. You will drive media fills, PPQs, and ensure regulatory readiness, while championing a digital-first, high-performance culture.

You will oversee cross-functional teams, implement innovative solutions, and guide the operation toward commercial readiness by 2028.