Director, ASAT Critical Reagent Operations
Core
Strategic and technical leadership for the commercial critical reagent program across the Cell Therapy manufacturing network, ensuring supply continuity, compliance, and lifecycle management for GMP Quality Control operations.
Role type
Director, Critical Reagent Operations (Cell Therapy)
Builds
Reliable patient supply and commercial growth for Cell Therapy products
Domain
Biopharmaceuticals / Cell Therapy / GMP Manufacturing
Required skills
Critical reagent lifecycle management, GMP Quality Control, supplier qualification, comparability strategies, risk management, network harmonization, regulatory compliance, cross-functional leadership, strategic planning, stakeholder management
Preferred skills
Advanced degree (MS/PhD), regulatory inspection experience, emerging technology evaluation, global health authority interactions
Technologies
GMP systems, analytical testing platforms, supply chain management tools
Responsibilities
Define and execute network strategy and governance for critical reagents; Establish standards for reagent qualification and lifecycle management; Lead reagent comparability assessments and bridging strategies; Drive network harmonization of specifications and testing requirements; Provide governance for supplier qualification and risk assessments; Lead inspection readiness activities and represent the organization during regulatory audits; Coach and mentor leaders and technical staff.
Seniority
Director, strategic leadership & team management