B87 Filling and Formulation Manager

Job Title: Aseptic Filling and Formulation ManagerLocation: Swiftwater, PAAbout the JobThis 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 OfferA rare opportunity to build operations from the ground up in a state-of-the-art aseptic facilityA leadership role at the center of a high-visibility startup and qualification programExposure to cutting-edge aseptic processing technology and next-generation manufacturing practicesCareer development and growth within a dynamic, expanding organizationA collaborative, innovative work environment that values curiosity, digital thinking, and challenging the status quoJoin 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 ResponsibilitiesLead 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 readinessDrive preparation and execution of Development Aseptic Process Simulations (media fills / APS) by Q4 2026Oversee PPQ execution and commercial readiness activities throughout 2027, ensuring inspection readiness by December 2027Apply innovative, analytically driven solutions to complex startup and qualification challengesChampion a digital-first approach to operations, leveraging technology, data analytics, and digital tools to optimize performance and decision-makingChallenge conventional processes and drive continuous improvement across the operationBuild and develop a high-performing, agile team aligned with company values and cultureEnsure strict GMP compliance and regulatory readiness at all timesWork effectively across cross-functional teams in a fast-paced, multi-priority startup environmentServe as Subject Matter Expert (SME) for aseptic operations during all Commissioning & Qualification (C&Q) and Validation activitiesStartup & Qualification LeadershipLead the operations team through all facility startup, commissioning, and qualification phasesDrive execution of Environmental Monitoring Performance Qualifications (EMPQs)Oversee smoke studies and cleanroom qualification activitiesLead Development Aseptic Process Simulations (media fills) beginning Q4 2026Direct PPQ execution in 2027 in accordance with validation protocols and regulatory expectationsDrive 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 ExcellenceOwn shift performance across aseptic filling and formulation operations in support of startup projects and/or routine manufacturing activitiesDrive execution performance using SMS 2.0 standards, routines, and digital toolsLeverage digital systems — including eOOE, iObeya, SAP, Qualipso, and Ocularis — to optimize operations, enable real-time decision-making, and maintain operational visibilityLead critical operational functions including 5W2Hs, Gembas, MSV/LSVs, real-time reviews, eBR approval, Sartocheck, Paltronic, and Ops Tracker auditsLead real-time problem solving in a dynamic, evolving environmentSupport on-time closure of quality items and deviations to meet site performance metrics and product release requirementsProvide analysis and recommendations to management on quality systems mattersParticipate in cost reduction and efficiency initiativesLeadership & Team DevelopmentBuild, lead, and develop a highly trained operations team from startup through commercial launchFoster a culture of learning, innovation, accountability, and challenging the status quoEmpower team members and ensure accountability at all levels of the organizationDemonstrate strong interpersonal and coaching behaviorsDrive cross-functional collaboration and process optimization across the facility and broader M&S organizationAssist with team development, training, and competency building throughout all phasesDigital Mindset & InnovationChampion digital transformation initiatives within operationsUtilize data analytics and digital tools to drive informed, real-time decision-makingIdentify and implement technology-enabled process improvementsLead adoption of Industry 4.0 principles within aseptic operationsModel a digital-first approach and encourage the team to leverage available technology to its fullest potentialAbout YouThis is a 2nd Shift leadership role, with flexible scheduling during startup and qualification phases. Basic QualificationsBachelor'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 requirementsProven leadership experience with the ability to build, develop, and manage teamsExcellent technical writing, communication, and interpersonal skillsAbility to work flexible hours, including extended shifts and weekends, to support qualification activities and production schedulesProficiency with digital systems and data analytics tools Preferred QualificationsExperience in facility or production line startup, commissioning, or qualification activitiesBackground in media fill execution and aseptic process validation (APS/PPQ)People management experience with a demonstrated track record of hiring and developing a new teamKnowledge of continuous improvement methodologies (Lean, Six Sigma, or equivalent)Experience with Lean manufacturing operating systemsFamiliarity with Industry 4.0 concepts and digital manufacturing toolsChange management experience in a regulated manufacturing environmentAbility to influence across functions and organizational levels without direct authorityPrevious experience in biologics, vaccines, or sterile drug product manufacturing.Soft Skills:Leadership Presence: Ability to inspire, develop, and hold teams accountable in a startup environmentDigital-First Mindset: Comfort leveraging technology, data, and digital platforms to drive operational performanceIntellectual Curiosity: Genuine desire to continuously learn, improve, and explore new approachesCourage to Challenge: Willingness to question the status quo and drive meaningful changeCritical Thinking: Strong analytical and problem-solving capabilities applied to complex qualification and operational challengesProactive Collaboration: Partners cross-functionally with a focus on optimization, efficiency, and shared outcomesCommunication Excellence: Communicates progress, issues, and resolution actions clearly and accurately across all organizational levelsAnticipation & Proactivity: Identifies and communicates constraints, conflicts, and risks before they escalateConflict Resolution: Resolves execution roadblocks within sphere of influence; escalates appropriately when neededAgility & Adaptability: Thrives in a fast-paced, multi-priority startup environment with evolving demandsAccountability & Ownership: Takes full ownership of team performance, quality outcomes, and operational resultsTIMELINE & EXPECTATIONS2025–2026 - Startup & Qualification, Facility startup, C&Q activities, EMPQs, Smoke Studies, Media FillsQ1 2027 - Development Aseptic Process Simulations (APS)2027 - PPQ Execution, PPQ campaigns, inspection readiness, regulatory preparation2028+ - Commercial Operations - Transition to routine commercial operations leadership. Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scaleTransform lives worldwide by delivering life-changing treatments anywhere, anytime.Sanofi US Services and its U.S. affiliates are