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
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.