B87 Filling and Formulation Manager

Job Title:

Aseptic Filling and Formulation Manager

Location:

Swiftwater, PA

This Aseptic Filling and Formulation Manager will lead aseptic filling and formulation operations in a new, state-of-the-art facility during a critical startup and qualification phase. You will be responsible for the overall safety, quality, compliance, productivity, and performance of your assigned team as the facility progresses through Development Aseptic Process Simulations (media fills) in Q4 2026 and Process Performance Qualifications (PPQs) in 2027, with a target of full commercial readiness in 2028.

You are a hands‑on, forward‑thinking leader who brings deep GMP expertise, a digital‑first mindset, and the courage to challenge conventional processes. You thrive in dynamic, fast‑paced environments and are energized by the opportunity to build something from the ground up. You lead with curiosity, inspire your team to continuously learn and improve, and hold yourself and others accountable to the highest standards.

Schedule

Note:

This role requires a flexible schedule during the startup and qualification phases, with a transition to an assigned shift (2nd or 3rd) during commercial operations. C&Q activities will predominantly occur on first shift; media fills, PPQs, and commercial launch activities will require shift‑aligned hours as applicable.

A rare opportunity to build operations from the ground up in a state‑of‑the‑art aseptic facility

A leadership role at the center of a high‑visibility startup and qualification program

Exposure to cutting‑edge aseptic processing technology and next‑generation manufacturing practices

Career development and growth within a dynamic, expanding organization

A collaborative, innovative work environment that values curiosity, digital thinking, and challenging the status quo

Join a global network that powers how Sanofi delivers, seamlessly, purposefully, and  Manufacturing & Supply, you’ll help reimagine how life‑changing treatments reach people everywhere, faster.

We’re an R&D‑driven, AI‑powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

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.

Work effectively across cross‑functional teams in a fast‑paced, multi‑priority startup environment.

Serve as Subject‑Matter Expert (SME) for aseptic operations during all Commissioning & Qualification (C&Q) and Validation activities.

Lead the operations team through all facility startup, commissioning, and qualification phases.

Drive execution of Environmental Monitoring Performance Qualifications (EMPQs).

Oversee smoke studies and cleanroom qualification activities.

Lead Development Aseptic Process Simulations (media fills) beginning Q4 2026.

Direct PPQ execution in 2027 in accordance with validation protocols and regulatory expectations.

Drive inspection readiness actions to ensure the facility is prepared for regulatory inspection (FDAPAI in 2027).

Ensure all C&Q activities are executed in…