B87 Filling and Form Manager 3rd Shift
Sanofi Group
Aumenta le possibilità di ricevere una risposta da questo datore di lavoro
Il tuo curriculum e una lettera di presentazione personalizzati, che corrispondono esattamente a ciò che sta cercando.
Descrizione del lavoro
Sanofi is seeking a B87 Filling and Form Manager on the 3rd shift in Swiftwater, PA to lead aseptic filling and formulation in a new state-of-the-art facility during startup and qualification phases. You will own safety, quality, compliance, productivity, and team performance as the facility progresses through media fills (APS) and PPQs toward commercial readiness.
You are a hands-on, GMP-expert leader with a digital-first mindset, capable of driving continuous improvement, cross-functional
Competenze
- Bachelor's degree in Life Sciences, Engineering, or related field with GMP manufacturing leadership experience.
- Demonstrated aseptic processing operations experience (Drug Substance/Product).
- Ability to work flexible hours including extended shifts and weekends for qualification activities.
- Experience with digital systems and data analytics tools.
Mansioni
- Lead startup operations for aseptic filling and formulation in a new facility.
- Drive Development Aseptic Process Simulations (media fills) by Q4 2026.
- Oversee PPQ execution and commercial readiness through 2027.
- Apply digital tools to optimize performance and decision-making.
- Ensure GMP compliance and regulatory readiness at all times.
- Lead cross-functional teamwork in a fast-paced startup environment.
Conoscenze
Formazione
Strumenti
Descrizione del lavoro
Job Title: B87 Filling and Form Manager - 3rd Shift
Location: Swiftwater, PA
This is a 3rd shift leadership role with flexible scheduling during startup and qualification phases.
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.
This role requires a flexible schedule during the startup and qualification phases, with a transition to 3rd shift 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.
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.
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 (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
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
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 escalated
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
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
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
A rare opportunity to build operations from the ground up in a state-of-the-art aseptic facility
A leadership role at the centre 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
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 scale
Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SP
#LI-SP
#VHD
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
'/%3e%3cpath%20d='M101.744%2012.4726L102.894%2016.1947L99.0021%2013.2201L101.744%2012.4726ZM105.3%208.40937H100.488L99.0026%203.59473L97.5116%208.41047L92.7%208.40385L96.5965%2011.3834L95.1055%2016.1942L99.0021%2013.2196L101.408%2011.3834L105.3%208.40992V8.40937Z'%20fill='white'/%3e%3cdefs%3e%3clinearGradient%20id='paint0_linear_5593_1381'%20x1='90'%20y1='9.44471'%20x2='99'%20y2='9.44471'%20gradientUnits='userSpaceOnUse'%3e%3cstop%20stop-color='%2300AD70'/%3e%3cstop%20offset='0.998594'%20stop-color='%2300B67A'/%3e%3cstop%20offset='1'%20stop-color='%23DCDCE6'/%3e%3c/linearGradient%3e%3c/defs%3e%3c/svg%3e){kind=small}
