Director of Sterility Assurance

The role

The Director of Sterility Assurance defines and implements the sterility assurance and contamination control strategy for autologous cell therapy manufacturing. This role provides strategic and operational leadership for aseptic processing, cleanroom operations, and microbiological quality systems.

What you will do

• Define, own, and govern the enterprise contamination control strategy for autologous cell therapy manufacturing.
• Establish risk-based microbial control strategies for autologous manufacturing workflows.
• Provide oversight of aseptic manufacturing operations including biosafety cabinet operations and cryopreservation.
• Support the strategy for environmental monitoring programs across GMP cleanrooms.
• Lead strategy for media fills and aseptic process simulations.
• Collaborate to ensure contamination control strategies are integrated with chain-of-identity and chain-of-custody controls.
• Serve as the sterility assurance SME during FDA inspections and pre-license inspections.
• Provide technical leadership for microbial and contamination investigations.
• Build and lead sterility assurance and contamination control teams.
• Partner with Manufacturing, Quality Assurance, QC Microbiology, and other departments.

Required qualifications

• Bachelor’s degree in Microbiology, Biological Sciences, Engineering, Pharmaceutical Sciences, or related discipline
• 12+ years of experience in sterile biologics, cell therapy, or aseptic pharmaceutical manufacturing
• Prior regulatory inspection experience

Nice to have

• Advanced degree
• Significant experience supporting autologous cell therapy or other patient-specific manufacturing operations
• Experience supporting late-stage clinical or commercial readiness activities, including BLA and PLI preparation
• Experience with autologous manufacturing workflows
• Experience with cryopreservation operations
• Experience with biosafety cabinet operations
• Experience with rapid sterility methods
• Experience with single-use systems
• Experience with decentralized manufacturing models
• Experience with chain-of-identity / chain-of-custody systems

Before you apply

• Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship

About the company

ProKidney is an equal employment opportunity employer.