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, Cell Therapy Critical Reagent Operations
Builds
Reliable patient supply and commercial growth for Cell Therapy products
Domain
Biopharmaceuticals / Cell Therapy / GMP Manufacturing
Required skills
Critical reagent lifecycle management, GMP compliance, network strategy, risk management, supplier qualification, comparability assessments, cross-functional leadership, regulatory inspection readiness, business continuity planning
Preferred skills
Advanced degree (MS/PhD), experience with regulatory inspections, emerging technology evaluation, enterprise-wide decision making
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; Coach and mentor technical leaders and staff
Seniority
Director, strategic leadership with hands-on technical oversight