ProKidney offers treatment of chronic kidney disease (CKD) through innovations in cellular therapy. Backed by North Carolina Biotechnology Center.
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
More about this role
The Director of Sterility Assurance is accountable for defining, implementing, and sustaining the sterility assurance and contamination control strategy for autologous cell therapy manufacturing operations supporting clinical and commercial programs at ProKidney.
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.
The Director will ensure compliance with FDA, EMA, and global GMP expectations for sterile and aseptic manufacturing, with particular emphasis on the unique risks associated with patient-specific autologous manufacturing, open manipulations, short manufacturing timelines, cryopreservation, and chain-of-identity/chain-of-custody controls.
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.
- Define, own, and govern the enterprise contamination control strategy (CCS) for autologous cell...
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