Director, Gene Therapy Manufacturing, Drug Su

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Full-time Regular Management - DIR Germantown, MD, US

Salary Range: $ To $ Annually

The Director, Gene Therapy Manufacturing, Drug Substance
, provides leadership, hands-on technical and operational expertise to the manufacturing team. This role is accountable for leading and shaping the current and future manufacturing teams for our clinical and commercial drug substance manufacturing, including project and site readiness, organizational design, and the establishment of operating rhythms, accountability, governance, culture, and performance standards.

The incumbent will lead tactical planning, cross-functional coordination, in collaboration with project management and MS&T, activities required for the continuous production of commercial product as well as successful site expansion and operational ramp-up. This is a key role in manufacturing operation that requires a highly dependable and disciplined leader with deep technical expertise in biological manufacturing unit operations (upstream and downstream), strong cGMP manufacturing knowledge, and proven operational leadership and people management skills.

Key Responsibilities:

Manufacturing Operations Leadership

• Build and enforce accountability and execution discipline across manufacturing teams.
• Lead manufacturing teams in operations across production, quality, materials, and support functions.
• Generate production schedules (for drug substance), requirements, quality standards, and ensure delivery commitments are met.
• Direct responsibility of on the floor activities and resolving manufacturing issues on the floor, real-time.
• Ensure manufacturing team is appropriately trained, qualified and documented to support safe and compliant operations.
• Translate technical requirements into production plans, labor needs, material requirements, timelines, and deliverables.
• Partner with MS&T and other functional groups in scale-up, technology transfer, implementation, and continuous improvement.
• Other duties as assigned

Production Planning and S&OP Support

• Accountable for adherence to production schedule by ensuring production systems (equipment, batch records, etc.) are qualified, documented, monitored and ready for production.
• Monitor labor, material, equipment, lead-time, and production risks to meet product demand.
• Ensure readiness plans, risk assessments, and implementation plans are developed and executed effectively.
• Other duties as assigned

Quality, Safety, and Compliance

• Promote and ensure production teams follow safety procedures, OSHA requirements, company policies, and work standards.
• Partner with quality leadership to ensure processes meet internal standards, customer requirements, and applicable regulatory or certification requirements.
• Ultimate responsibility of deviation management including, support corrective actions, root cause analysis, process control, documentation accuracy, and quality improvement.
• Other duties as assigned

Continuous Improvement and Lean Manufacturing

• Lead and/or support continuous improvement across production, engineering operations, materials flow, and manufacturing workflows.
• Apply Lean tools including 5S, Kaizen, root cause analysis, value stream mapping, visual management, standard work, and waste reduction.
• Improve productivity, yield, quality, delivery, labor efficiency, and overall operational effectiveness.
• Track KPIs such as on-time delivery, throughput, yield, downtime, rework, scrap, labor efficiency, and cost performance.
• Optimize capacity, labor, resources, workflow, and priorities to improve throughput, quality, cost, and scalability.
• Other duties as assigned

Team Leadership and Development

• Hire manufacturing operators, coach and develop managers and supervisors.
• Strengthen communication and accountability across production, facilities, quality, supply chain, and leadership.
• Support performance management, workforce planning, and leadership development.
• Create a performance-driven culture focused on quality, execution, problem-solving, and continuous improvement.
• Other duties as assigned

Requirements:

• Bachelor’s degree in Biology, Chemistry, Chemical Engineering, or a related scientific/technical discipline.
• 10+years of relevant cGMP experience in biologics, pharmaceutical or other regulated manufacturing environments, with hands-on experience in production unit…