Aseptic Filling & Formulation Leader – Startup & 2nd Shift

BioSpace

Swiftwater (Monroe County)

On-site

USD 180,000 - 240,000

Full time

6 days ago

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Job summary

Sanofi seeks an Aseptic Filling and Formulation Manager to lead startup and qualification of a new aseptic facility in Swiftwater, PA. You will be responsible for safety, quality, compliance, and overall performance of the operations team as the site moves through media fills, PPQs, and toward commercial readiness.

The role requires hands-on leadership, GMP expertise, and a digital-first mindset to optimize processes and drive continuous improvement across cross-functional teams during a dynamic

Qualifications

Bachelor's degree in Life Sciences or related field.
Proven GMP manufacturing operations experience.
Strong leadership and people management skills.
Experience with aseptic processing and validation activities.

Responsibilities

Lead startup operations for aseptic filling and formulation in a new facility environment.
Drive Development Aseptic Process Simulations (APS) by Q4 2026.
Oversee PPQ execution and commercial readiness activities through 2027.
Champion digital-first approach to operations with data analytics and digital tools.
Ensure GMP compliance and regulatory readiness at all times.
Lead cross-functional collaboration in a fast-paced startup environment.

Skills

Leadership

GMP expertise

Digital mindset

Team development

Quality systems

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or related field

Tools

SAP

Qualipso

iObeya

Ocularis

eOOE

Job description

The role requires hands-on leadership, GMP expertise, and a digital-first mindset to optimize processes and drive continuous improvement across cross-functional teams during a dynamic

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