Manufacturing Operations Leader - Upstream/Downstream

Job Title Deputy Director Manufacturing Operations Location Pearl River, NY About The Job Sanofi is seeking an experienced and driven Deputy Director of Manufacturing Operations to lead upstream and downstream manufacturing operations for the production of Flublok drug substance. This leadership role is responsible for managing three manufacturing teams and ensuring all areas are consistently ready for manufacturing operations in full compliance with regulatory and quality standards. The Deputy Director will serve as a key operational leader, driving a culture of continuous improvement, operational excellence, and accountability across their teams. This individual must bring a strong command of GMP/GDP requirements, Lean manufacturing principles, and people leadership to ensure reliable, high-quality drug substance production in support of Sanofi's mission to improve patient lives. About Sanofi We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Main Responsibilities Leadership & Team Management Ensure all areas and employees are safe at all times Directly manage three manufacturing teams supporting upstream and downstream Flublok drug substance operations Foster a high-performance culture grounded in accountability, collaboration, and continuous improvement Provide coaching, mentorship, and professional development to team members at all levels Effectively manage conflict within and across teams to maintain a productive and respectful work environment Drive a strong sense of urgency in day‑to‑day operations while maintaining quality and compliance standards Manufacturing Readiness & Operations Ensure manufacturing areas are consistently ready for scheduled production activities Oversee upstream and downstream manufacturing processes, including cell culture, protein production, purification, and related unit operations Monitor and manage production schedules to meet output targets while maintaining compliance with all applicable standards Ensure all equipment, materials, documentation, and personnel are in a state of readiness prior to manufacturing execution Quality, Compliance & Continuous Improvement Ensure all manufacturing activities are conducted in strict accordance with GMP (Good Manufacturing Practice) and GDP (Good Documentation Practice) requirements Lead and support deviation investigations, applying structured root cause analysis (RCA) methodologies to identify, document, and resolve manufacturing deviations Champion Lean manufacturing principles and defect identification practices to eliminate waste and drive process efficiency Implement and sustain performance management routines, including QDCI (Quality, Delivery, Cost, Involvement) metrics and visual management tools Partner with Quality Assurance and Regulatory Affairs to support inspections, audits, and regulatory submissions as needed Strategic & Cross‑Functional Collaboration Collaborate with Process Development, Quality, Supply Chain, and Engineering teams to support technology transfers, process improvements, and capacity planning Represent manufacturing in cross‑functional forums and contribute to site‑level strategic initiatives Identify and elevate risks to manufacturing readiness, supply continuity, or compliance in a timely manner Support the development and management of departmental budgets and resource planning About You Basic Qualifications Bachelor's degree in Engineering, Science, Life Sciences, Business, or a related field. 10+ years of experience in pharmaceutical or biopharmaceutical manufacturing, with 5+ years progressive leadership experience in a GMP environment. Strong working knowledge of GMP and GDP regulations and their application in a manufacturing environment Proven expertise in Lean manufacturing methodologies (5S, Gemba Problem Solving, Daily Capacity Management) and defect identification/reduction Demonstrated ability to perform thorough root cause analysis on manufacturing deviations and implement effective corrective actions Experience with performance management routines, including QDCI or equivalent operational excellence frameworks Strong conflict management skills with the ability to navigate interpersonal and team dynamics effectively Demonstrated sense of urgency and ability to prioritize and respond decisively in a fast‑paced manufacturing environment Excellent communication, organizational, and stakeholder management skills Understanding of cell growth and propagation principles as they apply to biopharmaceutical drug substance manufacturing Preferred Qualifications Advanced degree (MS, MBA, or PhD) in Life Sciences, Engineering, Business Administration, or a related technical field. Hands‑on experience with one or more of the following technologies: Single Use Systems Chromatography Tangential Flow Filtration Stainless Steel Systems (Fermenters and Bioreactors) 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. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally diverse 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. 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. #J-18808-Ljbffr Sanofi SA