B87 Filling and Form Manager 3rd Shift

Sanofi; Northern (KY); Hybrid; USD 140,000 - 200,000; Full time

Benefits offered by this job

14 weeks gender-neutral parental leave

Health benefits

Career development and growth

Job summary

Sanofi is seeking a dynamic leader to guide a startup aseptic manufacturing facility in the United States. The role focuses on startup, commissioning, and qualification, with emphasis on EMPQs, media fills, and PPQ execution.

You will drive regulatory readiness for FDA inspections and lead cross-functional teams to meet delivery goals. Applicants bring GMP manufacturing experience, strong communication skills, and a digital mindset to optimize performance using SAP, Qualipso, and other advanced

Qualifications

• Demonstrated aseptic processing and GMP manufacturing experience.
• Strong writing, communication, and interpersonal skills.
• Ability to lead startup, commissioning, and qualification activities.
• Experience with media fills and PPQ/APS validation.
• Familiarity with Industry 4.0 concepts and digital manufacturing tools.
• Proven ability to hire and develop new teams.

Responsibilities

• Lead the operations team through facility startup, commissioning, and qualification phases.
• Drive EMPQs, smoke studies, and cleanroom qualification activities.
• Direct PPQ execution and regulatory readiness for FDA inspections.
• Oversee real-time problem solving and deviation closure.
• Leverage SAP, Qualipso, and digital tools to optimize operations.
• Ensure compliance with cGMPs and regulatory expectations.

Skills

Leadership

Digital mindset

GMP knowledge

Regulatory compliance

Aseptic processing

Lean/Six Sigma

People management

Data analytics

Cross-functional collaboration

Education

Bachelor's in Life Sciences or Engineering

Alternative: High School Diploma + 5+ years GMP ops

Tools

SAP

Qualipso

Ocularis

iObeya

eOOE

Sartocheck

Paltronic

Ops Tracker

Job description

* 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 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* 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.