Director of Sterility Assurance

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.

Key Responsibilities

Sterility Assurance & Contamination Control Strategy

• Define, own, and govern the enterprise contamination control strategy (CCS) for autologous cell therapy manufacturing operations.
• Serve as an SME for sterility assurance, aseptic processing, and contamination control in cell therapy manufacturing environments.
• Establish risk-based microbial control strategies tailored to autologous manufacturing workflows and patient-specific processing.
• Ensure alignment of sterility assurance programs with:

• FDA aseptic processing guidance
• EU GMP Annex 1
• ATMP expectations
• applicable ICH guidance

Autologous Cell Therapy Manufacturing Support

• Provide oversight of aseptic manufacturing operations involving:

• patient-derived starting materials
• open and semi-closed manipulations
• biosafety cabinet operations
• cryopreservation activities
• final product handling and fill activities

• Define sterility-assurance requirements for manufacturing strategies that minimize operator intervention and contamination risk.
• Review and approve aseptic process workflows, interventions, and operator practices.
• Partner with Manufacturing and QC Micro to optimize contamination control during process scale-out and technology transfer.

Environmental Monitoring & Cleanroom Oversight

• Support the strategy for environmental monitoring (EM) programs across GMP cleanrooms and classified processing environments.
• Ensure robust trending and investigation of:

• viable and non-viable EM excursions
• personnel monitoring results
• contamination events
• aseptic process deviations

• Establish scientifically justified alert/action levels and escalation procedures.
• Oversee cleanroom qualification and ongoing state-of-control assessments.

Aseptic Process Simulation & Validation

• Lead strategy for media fills / aseptic process simulations (APS) representative of autologous manufacturing operations.
• Ensure APS programs appropriately model:

• extended manipulations
• worst-case interventions
• operator variability
• low-volume processing
• cryogenic handling steps

• Support qualification and validation activities for:

• biosafety cabinets
• isolators (if applicable)
• incubators
• cryostorage systems
• single-use manufacturing systems
• sterilizing filtration processes

Chain of Identity / Chain of Custody Risk Control

• Collaborate cross-functionally to ensure contamination control strategies are integrated with:

• chain-of-identity systems
• chain-of-custody controls
• material segregation procedures
• patient-specific manufacturing safeguards

• Assess operational risks associated with multi-product and multi-patient processing environments.

Regulatory Inspection Readiness

• Serve as the sterility assurance SME during:

• FDA inspections
• pre-license inspections (PLI)
• partner audits
• regulatory agency interactions

• Support preparation of regulatory filings and responses related to sterility assurance and aseptic manufacturing controls.
• Lead inspection readiness activities related to:

• contamination control strategy
• APS/media fills
• environmental monitoring
• microbial investigations
• aseptic operator qualification

Investigations, CAPA & Quality Systems

• Provide technical leadership for microbial and contamination investigations.
• Ensure timely, science-based root cause analysis and effective CAPA implementation.
• Review deviations, change controls, and risk assessments impacting sterile manufacturing operations.
• Drive continuous improvement initiatives to strengthen contamination prevention and operational robustness.

Cross-Functional Leadership

• Partner closely with:

• Manufacturing Operations
• Quality Assurance
• QC Microbiology
• MSAT
• Facilities & Engineering
• Supply Chain
• Regulatory Affairs

• Support strategic planning for commercial manufacturing readiness and network expansion.

Team Leadership

• Build and lead high-performing sterility assurance and contamination control teams.
• Develop training programs focused on:

• aseptic behaviors
• contamination prevention
• Annex 1 expectations
• GMP cleanroom practices

• Foster a strong quality culture emphasizing proactive risk identification and operational discipline.

Qualifications

Education

• Bachelor’s degree in Microbiology, Biological Sciences, Engineering, Pharmaceutical Sciences, or related discipline required.
• Advanced degree preferred.

Experience

• 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.

Technical Expertise

Deep expertise in:

• aseptic processing
• contamination control strategy development
• Annex 1 implementation
• environmental monitoring
• cleanroom operations
• microbial investigations
• media fill design and execution
• quality risk management (ICH Q9)
• GMP manufacturing for ATMPs/cell therapies

Preferred experience with:

• autologous manufacturing workflows
• cryopreservation operations
• biosafety cabinet operations
• rapid sterility methods
• single-use systems
• decentralized manufacturing models
• chain-of-identity / chain-of-custody systems

Leadership Competencies

• Strong executive communication and inspection interaction skills
• Ability to influence across Quality, Manufacturing, and Technical Operations
• Strategic systems-thinking capability
• Strong operational judgment under high-pressure manufacturing conditions
• Ability to build a proactive contamination-control culture
• Excellent mentoring and organizational leadership skills
• Exhibits TRAC Leadership values