Aseptic Filling & Formulation Lead — 3rd Shift Startup

Sanofi

Swiftwater (Monroe County)

On-site

USD 90,000 - 130,000

Full time

5 days ago
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Benefits offered by this job

Health insurance
401(k) or equivalent
Parental leave
Wellbeing programs

Job summary

Sanofi is seeking a B87 Filling and Form Manager for 3rd shift in Swiftwater, PA. This role leads aseptic filling and formulation, guiding startup activities, qualification phases, and eventual commercial readiness with a strong GMP, regulatory mindset and a digital‑first approach.

The candidate will oversee media fills, PPQ execution, and cross‑functional collaboration, while building and coaching a high‑performing team to achieve ambitious timelines and continuous improvement.

Qualifications

  • Bachelor's degree in Life Sciences, Engineering, or related field.
  • Experience in pharmaceutical/GMP manufacturing operations.
  • 1+ year of people leadership experience or formal leadership.
  • Demonstrated experience in aseptic processing operations.
  • Proficiency with digital systems and data analytics tools.

Responsibilities

  • Lead startup operations for aseptic filling and formulation in a new facility environment.
  • Drive Development Aseptic Process Simulations (media fills) by Q4 2026.
  • Oversee PPQ execution and commercial readiness activities in 2027.
  • Ensure GMP compliance and regulatory readiness at all times.
  • Lead cross‑functional collaboration and process optimization.

Skills

GMP expertise
Digital tools
Data analytics
Startup environment
Leadership

Education

Bachelor's degree in Life Sciences/Engineering

Tools

eOOE
iObeya
SAP
Qualipso
Ocularis

Job description

Sanofi is seeking a B87 Filling and Form Manager for 3rd shift in Swiftwater, PA. This role leads aseptic filling and formulation, guiding startup activities, qualification phases, and eventual commercial readiness with a strong GMP, regulatory mindset and a digital‑first approach.

The candidate will oversee media fills, PPQ execution, and cross‑functional collaboration, while building and coaching a high‑performing team to achieve ambitious timelines and continuous improvement.

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