Associate Director, Raw Materials MSAT

The Associate Director, Raw Materials Lead is accountable for establishing and leading the technical strategy, governance framework, and lifecycle management program for raw materials used in GMP manufacturing. The role translates CMC and manufacturing strategy into risk-based material control plans, qualification standards, supplier technical requirements, and ongoing performance monitoring.

This individual will serve as a key technical leader supporting BLA readiness, process validation, commercial launch preparation, and pre-license inspection (PLI) activities.

Key Responsibilities

• Develop and implement strategic frameworks for raw material knowledge transfer and lifecycle management
• Lead cross-functional initiatives to develop material control strategies that ensure product quality and manufacturability
• Partner with Quality Assurance and Supply Chain to define the technical elements of supplier qualification, supplier monitoring, change notification assessment, and supplier corrective action plans.
• Establish and manage the extractable/leachables program using risk based methodologies with external partners
• Establish and govern the cGMP visual inspection program, including defect standards, sampling approaches, training requirements, escalation criteria, and trend review.
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