# Director of Sterility Assurance at Prokidney Corp.

- Company: Prokidney Corp.
- What the company does: ProKidney offers treatment of chronic kidney disease (CKD) through innovations in cellular therapy. Backed by North Carolina Biotechnology Center.
- Company website: https://prokidney.com
- Type: Startups
- Level: Principal and up
- Location: Winston-Salem, North Carolina, United States
- Work setup: On-site
- Posted: 2026-09-28
- Apply by: 2026-11-12
- Apply: https://job-boards.greenhouse.io/prokidney/jobs/5250718007
- Page: https://www.1752.vc/careers/jobs/prokidney-corp-director-of-sterility-assurance/

## About the role

This role provides strategic and operational leadership for aseptic processing, contamination control, environmental monitoring, cleanroom operations, microbiological quality systems, and inspection readiness across centralized manufacturing activities associated with autologous renal cell therapy products. This individual will serve as a key technical and quality leader supporting BLA readiness, process validation, commercial launch preparation, and pre-approval inspection (PLI) activities.

## What they're looking for

- 12+ years of experience in sterile biologics, cell therapy, or aseptic pharmaceutical manufacturing
- Significant experience supporting autologous cell therapy or other patient-specific manufacturing operations strongly preferred
- Demonstrated experience supporting late-stage clinical or commercial readiness activities, including BLA and PLI preparation
- Prior regulatory inspection experience required

Tags: MS&T

Source: 1752vc Careers, https://www.1752.vc/careers/jobs/prokidney-corp-director-of-sterility-assurance/