Director, Sterility Assurance & Contamination Control

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

Job summary

ProKidney Corp. is seeking a Director of Sterility Assurance to define and execute the strategy for sterility, contamination control, and aseptic processing across autologous cell therapy manufacturing.

The role ensures compliance with FDA/EMA GMPs, leads environmental monitoring, and supports BLA readiness and PLI activities. You will oversee cross-functional teams, drive risk-based microbial control, and partner with Manufacturing, QA, and Regulatory Affairs to enable clinical and commercial

Qualifications

• Bachelor’s degree required in related field.
• Advanced degree preferred.

Responsibilities

• Define, implement, and sustain the sterility assurance and contamination control strategy for autologous cell therapy manufacturing operations.
• Provide leadership for aseptic processing, contamination control, environmental monitoring, cleanroom operations, microbial quality systems, and inspection readiness.
• Ensure compliance with FDA, EMA, and global GMP expectations for sterile and aseptic manufacturing, including open manipulations, short timelines, cryopreservation, and chain-of-identity/custody controls.
• Lead BLA readiness, process validation, commercial launch preparation, and pre-approval inspections (PLI).
• Oversee regulatory inspection readiness and quality system improvements related to sterility assurance.

Education

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

Job description

ProKidney Corp. is seeking a Director of Sterility Assurance to define and execute the strategy for sterility, contamination control, and aseptic processing across autologous cell therapy manufacturing.

The role ensures compliance with FDA/EMA GMPs, leads environmental monitoring, and supports BLA readiness and PLI activities. You will oversee cross-functional teams, drive risk-based microbial control, and partner with Manufacturing, QA, and Regulatory Affairs to enable clinical and commercial