Director of Sterility Assurance

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.

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

Autologous Cell Therapy Manufacturing Support

1. 9Provide oversight of aseptic manufacturing operations involving:

1. 10patient-derived starting materials
2. 11open and semi-closed manipulations
3. 12biosafety cabinet operations
4. 13cryopreservation activities
5. 14final product handling and fill activities

1. 15Define sterility-assurance requirements for manufacturing strategies that minimize operator intervention and contamination risk.
2. 16Review and approve aseptic process workflows, interventions, and operator practices.
3. 17Partner with Manufacturing and QC Micro to optimize contamination control during process scale-out and technology transfer.

Environmental Monitoring & Cleanroom Oversight

1. 18Support the strategy for environmental monitoring (EM) programs across GMP cleanrooms and classified processing environments.
2. 19Ensure robust trending and investigation of:

1. 20viable and non-viable EM excursions
2. 21personnel monitoring results
3. 22contamination events
4. 23aseptic process deviations

1. 24Establish scientifically justified alert/action levels and escalation procedures.
2. 25Oversee cleanroom qualification and ongoing state-of-control assessments.

Aseptic Process Simulation & Validation

1. 26Lead strategy for media fills / aseptic process simulations (APS) representative of autologous manufacturing operations.
2. 27Ensure APS programs appropriately model:

1. 28extended manipulations
2. 29worst-case interventions
3. 30operator variability
4. 31low-volume processing
5. 32cryogenic handling steps

1. 33Support qualification and validation activities for:

1. 34biosafety cabinets
2. 35isolators (if applicable)
3. 36incubators
4. 37cryostorage systems
5. 38single-use manufacturing systems
6. 39sterilizing filtration processes

Chain of Identity / Chain of Custody Risk Control

1. 40Collaborate cross-functionally to ensure contamination control strategies are integrated with:

1. 41chain-of-identity systems
2. 42chain-of-custody controls
3. 43material segregation procedures
4. 44patient-specific manufacturing safeguards

1. 45Assess operational risks associated with multi-product and multi-patient processing environments.

Regulatory Inspection Readiness

1. 46Serve as the sterility assurance SME during:

1. 47FDA inspections
2. 48pre-license inspections (PLI)
3. 49partner audits
4. 50regulatory agency interactions

1. 51Support preparation of regulatory filings and responses related to sterility assurance and aseptic manufacturing controls.
2. 52Lead inspection readiness activities related to:

1. 53contamination control strategy
2. 54APS/media fills
3. 55environmental monitoring
4. 56microbial investigations
5. 57aseptic operator qualification

Investigations, CAPA & Quality Systems

1. 58Provide technical leadership for microbial and contamination investigations.
2. 59Ensure timely, science-based root cause analysis and effective CAPA implementation.
3. 60Review deviations, change controls, and risk assessments impacting sterile manufacturing operations.
4. 61Drive continuous improvement initiatives to strengthen contamination prevention and operational robustness.

Cross-Functional Leadership

1. 62Partner closely with:

1. 63Manufacturing Operations
2. 64Quality Assurance
3. 65QC Microbiology
4. 66MSAT
5. 67Facilities & Engineering
6. 68Supply Chain
7. 69Regulatory Affairs

1. 70Support strategic planning for commercial manufacturing readiness and network expansion.

Team Leadership

1. 71Build and lead high-performing sterility assurance and contamination control teams.
2. 72Develop training programs focused on:

1. 73aseptic behaviors
2. 74contamination prevention
3. 75Annex 1 expectations
4. 76GMP cleanroom practices

1. 77Foster a strong quality culture emphasizing proactive risk identification and operational discipline.