B87 Formulation and Filling Manager

Location: Swiftwater, PA

About the role

This Production Manager – B87 Aseptic Filling & Formulation 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.

Sanofi is 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.

Responsibilities

• Lead startup operations for aseptic filling and formulation in a new facility, serving as the operational anchor through 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, 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.
• 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 execution of Environmental Monitoring Performance Qualifications (EMPQs) and oversee smoke studies and cleanroom qualification activities.
• Own shift performance across aseptic filling and formulation operations, using SMS 2.0 standards, routines, and digital tools.
• Leverage digital systems—including eOOE, iObeya, SAP, Qualipso, and Ocularis—to enable real‑time decision‑making and maintain operational visibility.
• Lead critical operational functions such as 5W2Hs, Gembas, MSV/LSVs, real‑time reviews, eBR approval, Sartocheck, Paltronic, and Ops Tracker audits.
• Provide real‑time problem solving, support on‑time closure of quality items and deviations, and deliver analysis and recommendations 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.
• Drive cross‑functional collaboration and process optimization across the facility and broader M&S organization.
• Champion digital transformation initiatives, utilize data analytics to drive informed decision‑making, and implement technology‑enabled process improvements.
• Model a digital‑first approach and encourage the team to leverage available technology to its fullest potential.

Key Competencies

• Leadership Presence – ability to inspire, develop, and hold teams accountable in a startup environment.
• Digital‑First Mindset – comfort leveraging technology, data, and digital platforms to drive operational performance.
• Intellectual Curiosity – genuine desire to continuously learn, improve, and explore new approaches.
• Courage to Challenge – willingness to question the status quo and drive meaningful change.
• Critical Thinking – strong analytical and problem‑solving capabilities applied to complex qualification and operational challenges.
• Proactive Collaboration – partners cross‑functionally with a focus on optimization, efficiency, and shared outcomes.
• Communication Excellence – communicates progress, issues, and resolution actions clearly and accurately across all organizational levels.
• Anticipation & Proactivity – identifies and communicates constraints, conflicts, and risks before they escalate.
• Conflict Resolution – resolves execution roadblocks within sphere of influence; escalates appropriately when needed.
• Agility & Adaptability – thrives in a fast‑paced, multi‑priority startup environment with evolving demands.
• Accountability & Ownership – takes full ownership of team performance, quality outcomes, and operational results.

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, or High School Diploma with 5+ years of pharmaceutical/GMP manufacturing operations experience and 1+ year of people‑leadership experience.
• 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 SMS 2.0 or similar 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.

Compensation

All compensation will be determined commensurate with demonstrated experience.

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.
• A thoughtful, well‑crafted rewards package that recognizes your contribution and amplifies your impact.
• Comprehensive health and wellbeing benefits, including high‑quality healthcare, prevention and wellness programs, and at least 14 weeks of gender‑neutral parental leave.
• Opportunities to shape the future of medicine and vaccine delivery with cutting‑edge technology, ensuring seamless launches and a resilient global supply.
• Ability to leverage digital, data, and AI‑driven innovation to power industry‑leading performance.