Aseptic Filling & Formulation Lead - 3rd Shift (Startup)

BioSpace; Swiftwater (Monroe County); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

State-of-the-art facility

Startup leadership program

Career development

Competitive compensation

Health benefits

Job summary

Sanofi Inc. seeks a B87 Filling and Form Manager for 3rd shift to lead aseptic filling and formulation in a new state-of-the-art facility during startup and qualification phases.

You will own safety, quality, compliance, productivity, and team performance as the facility progresses through media fills and PPQs with a goal of commercial readiness by 2028. You are a hands-on, GMP-experienced leader who embraces a digital-first mindset, analyzes data, and challenges conventional processes.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field with GMP manufacturing ops experience and 6+ months of people leadership experience OR High School Diploma with 5+ years of GMP manufacturing ops experience and 1+ years of leadership experience.
• Demonstrated experience in aseptic processing operations (Drug Substance, Drug Product, Biologics).
• Proficiency with digital systems and data analytics tools.

Responsibilities

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

Skills

Leadership

GMP compliance

Digital mindset

Cross-functional

Problem solving

Communication

Shift flexibility

Education

Bachelor's degree in Life Sciences or related field

High School Diploma + 5+ years GMP experience

Tools

SAP

Qualipso

Ocularis

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Job description

Sanofi Inc. seeks a B87 Filling and Form Manager for 3rd shift to lead aseptic filling and formulation in a new state-of-the-art facility during startup and qualification phases.

You will own safety, quality, compliance, productivity, and team performance as the facility progresses through media fills and PPQs with a goal of commercial readiness by 2028. You are a hands-on, GMP-experienced leader who embraces a digital-first mindset, analyzes data, and challenges conventional processes.