Autologous cellular therapy for chronic kidney disease in Phase 2/3 trials
ProKidney develops rilparencel, a first-in-class autologous cellular therapy for diabetic kidney disease, currently in Phase 2 and Phase 3 clinical evaluation with FDA RMAT designation. The hiring mix—dominated by manufacturing (8 roles) and quality (3 roles) with accelerating velocity—reflects a company transitioning from research to GMP-scale manufacturing and compliance readiness, a phase typically marked by operational friction around process deviation, inspection prep, and digital manufacturing integration.
Notable leadership hires: Director, Quality Operations, Scientific Director
ProKidney is a clinical-stage biotherapeutics company focused on treating chronic kidney disease through cellular therapy innovations. The company's lead candidate, rilparencel (REACT®), is designed to preserve kidney function in diabetic patients at high risk of progression to kidney failure. Founded in 2015 after a decade of prior research, ProKidney is headquartered in Winston-Salem, North Carolina, and operates as a public company. Current operational focus spans clinical trial execution, manufacturing scale-up, and regulatory compliance preparation.
Rilparencel (REACT®), a first-in-class autologous cellular therapy in Phase 2 and Phase 3 studies for diabetic kidney disease. It has FDA Regenerative Medicine Advanced Therapy (RMAT) designation.
RNA-seq, ATAC-seq, 10x Genomics, RT-qPCR, and LIMS for assay execution; Python, R, Tableau, and Spotfire for data analysis and visualization.
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