Aseptic Filling Ops Lead — 3rd Shift (Startup/Qualification)

Sanofi; Northern (KY); Hybrid; USD 140,000 - 200,000; Full time

Benefits offered by this job

14 weeks gender-neutral parental leave

Health benefits

Career development and growth

Job summary

Sanofi is seeking a dynamic leader to guide a startup aseptic manufacturing facility in the United States. The role focuses on startup, commissioning, and qualification, with emphasis on EMPQs, media fills, and PPQ execution.

You will drive regulatory readiness for FDA inspections and lead cross-functional teams to meet delivery goals. Applicants bring GMP manufacturing experience, strong communication skills, and a digital mindset to optimize performance using SAP, Qualipso, and other advanced

Qualifications

• Demonstrated aseptic processing and GMP manufacturing experience.
• Strong writing, communication, and interpersonal skills.
• Ability to lead startup, commissioning, and qualification activities.
• Experience with media fills and PPQ/APS validation.
• Familiarity with Industry 4.0 concepts and digital manufacturing tools.
• Proven ability to hire and develop new teams.

Responsibilities

• Lead the operations team through facility startup, commissioning, and qualification phases.
• Drive EMPQs, smoke studies, and cleanroom qualification activities.
• Direct PPQ execution and regulatory readiness for FDA inspections.
• Oversee real-time problem solving and deviation closure.
• Leverage SAP, Qualipso, and digital tools to optimize operations.
• Ensure compliance with cGMPs and regulatory expectations.

Skills

Leadership

Digital mindset

GMP knowledge

Regulatory compliance

Aseptic processing

Lean/Six Sigma

People management

Data analytics

Cross-functional collaboration

Education

Bachelor's in Life Sciences or Engineering

Alternative: High School Diploma + 5+ years GMP ops

Tools

SAP

Qualipso

Ocularis

iObeya

eOOE

Sartocheck

Paltronic

Ops Tracker

Job description

Sanofi is seeking a dynamic leader to guide a startup aseptic manufacturing facility in the United States. The role focuses on startup, commissioning, and qualification, with emphasis on EMPQs, media fills, and PPQ execution.

You will drive regulatory readiness for FDA inspections and lead cross-functional teams to meet delivery goals. Applicants bring GMP manufacturing experience, strong communication skills, and a digital mindset to optimize performance using SAP, Qualipso, and other advanced