B87 Filling and Formulation Manager

Job Title : Aseptic Filling and Formulation Manager

Location: Swiftwater, PA

About the Job

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.

What We Offer

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 at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi:

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.

Main Responsibilities

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

Startup & Qualification Leadership

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 (FDA PAI in 2027)

Ensure all C&Q activities are executed in compliance with applicable regulatory standards (cGMPs, CBER, WHO, EP, and other governing bodies)

Operational Excellence

Own shift performance across aseptic filling and formulation operations in support of startup projects and/or routine manufacturing activities

Drive execution performance using SMS 2.0 standards, routines, and digital tools

Leverage digital systems — including eOOE, iObeya, SAP, Qualipso, and Ocularis — to optimize operations, enable real-time decision-making, and maintain operational visibility

Lead critical operational functions including 5W2Hs, Gembas, MSV/LSVs, real-time reviews, eBR approval, Sartocheck, Paltronic, and Ops Tracker audits

Lead real-time problem solving in a dynamic, evolving environment

Support on-time closure of quality items and deviations to meet site performance metrics and product release requirements

Provide analysis and recommendations to management on quality systems matters

Participate in cost reduction and efficiency initiatives

Leadership & Team Development

Build, lead, and develop a highly trained operations team from startup through commercial launch

Foster a culture of learning, innovation, accountability, and challenging the status quo

Empower team members and ensure accountability at all levels of the organization

Demonstrate strong interpersonal and coaching behaviors

Drive cross-functional collaboration and process optimization across the facility and broader M&S organization

Assist with team development, training, and competency building throughout all phases

Digital Mindset & Innovation

Champion digital transformation initiatives within operations

Utilize data analytics and digital tools to drive informed, real-time decision-making

Identify and implement technology-enabled process improvements

Lead adoption of Industry 4.0 principles within aseptic operations

Model a digital-first approach and encourage the team to leverage available technology to its fullest potential

About You

This is a 2nd Shift leadership role, with flexible scheduling during startup and qualification phases.

Basic Qualifications

Bachelor's degree in Life Sciences, Engineering, or a related field with 1+ years of pharmaceutical/GMP manufacturing operations experience and 6+ months of people leadership experience (formal or demonstrated leadership capability, e.g., team captain, project lead, supervisory role) OR High School Diploma with 5+ years of pharmaceutical/GMP manufacturing operations experience and 1+ years of people leadership experience (formal or demonstrated leadership capability, e.g., team captain, project lead, supervisory role)

Demonstrated experience in aseptic processing operations (Drug Substance, Drug Product, Biologics)

Strong working knowledge of GMPs and regulatory compliance requirements

Proven leadership experience with the ability to build, develop, and manage teams

Excellent technical writing, communication, and interpersonal skills

Ability to work flexible hours, including extended shifts and weekends, to support qualification activities and production schedules

Proficiency with digital systems and data analytics tools

Preferred Qualifications

Experience in facility or production line startup, commissioning, or qualification activities

Background in media fill execution and aseptic process validation (APS/PPQ)

People management experience with a demonstrated track record of hiring and developing a new team

Knowledge of continuous improvement methodologies (Lean, Six Sigma, or equivalent)

Experience with Lean manufacturing operating systems

Familiarity with Industry 4.0 concepts and