Job Title: Aseptic Filling and Formulation Manager
Location: Swiftwater, PA
About 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.
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 YouThis 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 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.
Soft Skills:- 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
TIMELINE & EXPECTATIONS- [redacted] - Startup & Qualification, Facility startup, C&Q activities, EMPQs, Smoke Studies, Media Fills
- Q1 2027 - Development Aseptic Process Simulations (APS)
- 2027 - PPQ Execution, PPQ campaigns, inspection readiness, regulatory preparation
- 2028+ - 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 scale
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
The salary range for this position is:
$90.000,00 - $130.000,00
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.
