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