Sanofi
DeputyDirectorManufacturingOperations
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“Deputy Director Manufacturing Operations at Sanofi. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, GMP/GDP requirements, Lean manufacturing principles, people leadership. Lead upstream and downstream manufacturing operations for the production of Flublok drug substance.. Manage three manufacturing teams.”
What You'll Achieve.
Ensure reliable, high-quality drug substance production in support of Sanofi's mission to improve patient lives.; Meet output targets while maintaining compliance with all applicable standards.; Eliminate waste and drive process efficiency.
Industry & Context.
root cause analysis (RCA); Gemba Problem Solving; defect identification/reduction
What They're Looking For.
Must Have
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 GMP environment., 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, 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
Nice to Have
Advanced degree (MS, MBA, or PhD) Life Sciences, Engineering, Business Administration or 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)
What You'll Do.
Lead upstream and downstream manufacturing operations for the production of Flublok drug substance.
Manage three manufacturing teams.
Ensure all areas are consistently ready for manufacturing operations in full compliance with regulatory and quality standards.
Drive a culture of continuous improvement
operational excellence
Ensure all areas and employees are safe at all times.
Foster a high-performance culture grounded in accountability
and continuous improvement.
and professional development to team members.
Effectively manage conflict within and across teams.
Drive a sense of urgency in day-to-day operations while maintaining quality and compliance standards.
Ensure manufacturing areas are consistently ready for scheduled production activities.
Oversee upstream and downstream manufacturing processes
including cell culture
and related unit operations.
Monitor and manage production schedules to meet output targets while maintaining compliance with all applicable standards.
and personnel are in a state of readiness prior to manufacturing execution.
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.
Champion Lean manufacturing principles and defect identification practices.
Implement and sustain performance management routines
including +QDCI (Quality
Involvement) metrics and visual management tools.
Partner with Quality Assurance and Regulatory Affairs to support inspections
and regulatory submissions.
Collaborate with Process Development
and Engineering teams to support technology transfers
and capacity planning.
Represent manufacturing in cross-functional forums and contribute to site-level strategic initiatives.
Identify and escalate risks to manufacturing readiness
Support the development and management of departmental budgets and resource planning.
How You'll Work.
Team & Collaboration
cross-functional coordination; Foster a high-performance culture grounded in accountability, collaboration, and continuous improvement; Effectively manage conflict within and across teams; Partner with Quality Assurance and Regulatory Affairs to support inspections, audits, and regulatory submissions; 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
Communication Scope
Excellent communication skills
Process & Methodology
process management, resource planning, capacity planning, departmental budgets
Full Job Description
**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
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