Senior Raw Materials MSAT Lead — Biologics & CGT

ProKidney Corp.; Winston-Salem (NC); Hybrid; USD 140,000 - 180,000; Full time

Job summary

ProKidney Corp. in Winston-Salem, NC, seeks an Associate Director, Raw Materials Lead to establish and drive the technical strategy, governance, and lifecycle management for GMP raw materials. This role translates CMC and manufacturing strategy into risk‑based material control plans and supplier requirements.

The incumbent will support BLA readiness, process validation, and pre‑license inspection activities, leading risk assessments and supplier evaluations across QA, MSAT, and regulatory teams.

Qualifications

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

Responsibilities

• Develop and lead strategic frameworks for raw material knowledge transfer and lifecycle management.
• Lead cross‑functional initiatives to define material control strategies for product quality and manufacturability.
• Partner with QA and Supply Chain on supplier qualification, monitoring, change notification assessment, and CAPA plans.
• Establish and manage extractable/leachables program using risk‑based methods with external partners.
• Govern the cGMP visual inspection program, including defect standards, sampling, training, escalation, and trend reviews.
• Define critical material attributes and link to process performance and robustness; act as raw material SME within CMC teams.
• Conduct risk assessments, supplier evaluations, and manage post‑approval changes related to raw materials.
• Collaborate on regulatory submissions and health authority interactions regarding material science topics.
• Ensure timely, science‑based root cause analysis and effective CAPA for raw material deviations and proactive initiatives.
• Review deviations, change controls, and risk assessments impacting raw material operations; include vendor notifications.
• Drive continuous improvement to strengthen raw material program robustness.

Skills

Leadership

CMC knowledge

Regulatory

Risk assessment

Material lifecycle

Education

Bachelor's degree in Biological Sciences

Advanced degree preferred

Job description

ProKidney Corp. in Winston-Salem, NC, seeks an Associate Director, Raw Materials Lead to establish and drive the technical strategy, governance, and lifecycle management for GMP raw materials. This role translates CMC and manufacturing strategy into risk‑based material control plans and supplier requirements.

The incumbent will support BLA readiness, process validation, and pre‑license inspection activities, leading risk assessments and supplier evaluations across QA, MSAT, and regulatory teams.