B87 Filling and Formulation Manager

Sanofi•Swiftwater, PA

8d•$90,000 - $130,000•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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 digital manufacturing tools
Change management experience in a regulated manufacturing environment
Ability to influence across functions and organizational levels without direct authority
Previous experience in biologics, vaccines, or sterile drug product manufacturing.

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
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)
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
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
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