Director, Sterility Assurance & Contamination Control

ProKidney Corp.; White Settlement (TX); On-site; USD 180,000 - 240,000; Full time

Job summary

ProKidney Corp. in the United States seeks a Director of Sterility Assurance to define and sustain the sterility strategy for autologous cell therapy manufacturing supporting clinical and commercial programs.

You will provide strategic leadership across aseptic processing, contamination control, environmental monitoring, cleanroom operations, and quality systems, ensuring FDA/EMA/GMP compliance and readiness for inspections.

Qualifications

• Bachelor's degree in Microbiology, Biological Sciences, Engineering, Pharmaceutical Sciences, or related discipline required.
• 12+ years of experience in sterile biologics, cell therapy, or aseptic pharmaceutical manufacturing.
• Experience supporting autologous cell therapy manufacturing and regulatory readiness preferred.
• Prior regulatory inspection experience required.

Responsibilities

• Define, own, and govern the enterprise contamination control strategy for autologous manufacturing operations.
• Oversee aseptic processing, contamination control, and environmental monitoring in cell therapy operations.
• Ensure alignment with FDA aseptic processing guidance, EU Annex 1, ATMP expectations, and ICH guidance.
• Lead media fills and APS programs representing autologous manufacturing operations.
• Collaborate on chain-of-identity and chain-of-custody controls to minimize risks.
• Prepare for regulatory inspections and contribute to BLA/PLI readiness.
• Provide technical leadership for microbial investigations and CAPA.
• Build and lead sterility assurance and contamination-control teams.

Skills

Sterility assurance

Aseptic processing

Environmental monitoring

Contamination control

Regulatory compliance

Education

Bachelor's degree in Microbiology, Biology, Engineering, or related field

Job description

ProKidney Corp. in the United States seeks a Director of Sterility Assurance to define and sustain the sterility strategy for autologous cell therapy manufacturing supporting clinical and commercial programs.

You will provide strategic leadership across aseptic processing, contamination control, environmental monitoring, cleanroom operations, and quality systems, ensuring FDA/EMA/GMP compliance and readiness for inspections.