ProKidney offers treatment of chronic kidney disease (CKD) through innovations in cellular therapy. Backed by North Carolina Biotechnology Center.
About the role
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.
What they're looking for
- 10+ years of experience in biologics or cell and gene therapy (CGT),
- Significant experience supporting autologous cell therapy, CGT or other patient-specific manufacturing operations strongly preferred
- Demonstrated experience supporting late-stage clinical or commercial readiness activities, including BLA and PLI preparation
- Deep knowledge of CMC processes for biologics, CGT or Cell Therapy platforms, including technology transfer and lifecycle management
- Proven expertise in raw material risk assessments, characterization, and control strategies for GMP manufacturing
- Strong organizational, problem-solving, and communication skills with the ability to influence decisions across teams
More about this role
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.
- 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...
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