Job Title: Deputy Director Manufacturing Operations
Location: Pearl River, NY
Main ResponsibilitiesLeadership & Team Management- Ensure all areas and employees are safe at all times
- Directly manage 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, clarification, 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 escalate risks to manufacturing readiness, supply continuity, or compliance in a timely manner
- Support the development and management of departmental budgets and resource planning
About YouBasic Qualifications- Bachelor's degree in engineering, Science, Life Sciences, Business, or any related field.
- 5 -7 years of experience in pharmaceutical or biopharmaceutical manufacturing.
- 5+ years of progressive, hands-on leadership experience in a GMP manufacturing environment, with an expectation to interact with and solve problems at the shop floor level.
- 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) in 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)
The salary range for this position is:
$133.500,00 - $192.833,33
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.
