Senior Raw Materials MSAT Leader — Strategy & Quality

ProKidney Corp.; Winston-Salem (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

ProKidney Corp. seeks an Associate Director, Raw Materials Lead to establish and lead the technical strategy, governance, and lifecycle management program for raw materials used in GMP manufacturing.

You will translate CMC and manufacturing strategy into risk-based material control plans and supplier standards, while monitoring ongoing performance. You will support BLA readiness, process validation, commercial launch preparation, and pre-license inspection activities, partnering with QA,

Qualifications

• Bachelor’s degree in Biological Sciences, Engineering, Pharmaceutical Sciences, or related discipline.
• Advanced degree preferred.

Responsibilities

• Establish and lead technical strategy, governance framework, and lifecycle management for raw materials used in GMP manufacturing.
• Translate CMC and manufacturing strategy into risk-based material control plans, qualification standards, supplier requirements, and ongoing performance monitoring.
• Partner with Quality Assurance and Supply Chain to define supplier qualification, monitoring, change notification assessment, and CAPA plans.
• Establish and manage extractable/leachables program using risk-based methodologies with external partners.
• Define critical material attributes linked to process performance and robustness.

Skills

CMC knowledge

Regulatory knowledge

Project leadership

Risk assessment

Education

Bachelor’s degree in Biological Sciences, Engineering, Pharmaceutical Sciences, or related discipline

Advanced degree preferred

Job description

ProKidney Corp. seeks an Associate Director, Raw Materials Lead to establish and lead the technical strategy, governance, and lifecycle management program for raw materials used in GMP manufacturing.

You will translate CMC and manufacturing strategy into risk-based material control plans and supplier standards, while monitoring ongoing performance. You will support BLA readiness, process validation, commercial launch preparation, and pre-license inspection activities, partnering with QA,