Director, Validation
Cabaletta Bio
August 11, 2026
Remote friendly (Philadelphia, PA)
United States
Operations
Position Summary
- Develop, implement, and maintain the laboratory validation program supporting Research, Translational Medicine, Manufacturing Sciences & Technology, Analytical/Process Development, and other lab functions.
- Provide strategic and operational leadership for qualification and validation of laboratory instruments/equipment, computerized systems, and supporting infrastructure to ensure FDA/EMA/ICH/GxP compliance for BLA submission and commercial launch.
- Establish a sustainable, risk-based validation lifecycle for advanced therapies and autologous cell therapy products; ensure validated systems generate reliable, attributable, inspection-ready data.
Primary Responsibilities
Validation Program Leadership
- Develop/execute validation roadmap from clinical-stage development through BLA and commercial launch.
- Establish governance; develop validation policies/procedures/standards/templates; build scalable validation framework; drive continuous improvement.
Equipment and Instrument Qualification
- Lead IQ/OQ/PQ, requalification, and decommissioning; ensure documentation is scientifically justified and risk-based; define strategies based on intended use, patient safety, and data integrity risk.
Computerized Systems Validation (CSV)
- Validate LIMS, ELN, instrument software, scientific applications, and data acquisition systems; ensure compliance with 21 CFR Part 11, Annex 11, ALCOA+ and GAMP 5; manage lifecycle/updates with IT and system owners.
Inspection Readiness & Quality Systems
- Create inspection-ready documentation for FDA audits; ensure packages are complete/traceable; serve as SME; lead remediation.
- Integrate with Quality Management System; review/approve key validation documents; support change control; investigate deviations; monitor metrics.
Cross-Functional Leadership & Vendor/People Leadership
- Partner with QA/QC, R&D, IT, and external labs; provide validation expertise for expansion/tech transfer/automation; assess validation impact of new technologies.
- Oversee vendor deliverables; build/mentor validation organization.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Computer Science, Pharmaceutical Sciences, or related.
- 12+ years in biotech/pharma/cell therapy/gene therapy/biologics; 5+ years leading validation organizations.
- Experience supporting BLA/NDA or commercial biologics submissions.
- Experience establishing validation programs in rapidly growing orgs; positive FDA inspection experience.
- Strong knowledge of advanced therapy laboratory operations.
Technical Expertise (Extensive Knowledge Of)
- IQ/OQ/PQ; CSV; risk-based validation; GAMP 5; 21 CFR Parts 11, 210, 211, 600 series; 21 CFR Part 58 (as applicable); ICH Q9/Q10; FDA data integrity guidance; EU GMP Annex 11; ALCOA+; validation lifecycle management; lab automation; analytical instrumentation.
Experience With
- Flow cytometry platforms, cell counting instruments, PCR/qPCR, bioanalytical instrumentation, laboratory information systems, scientific software applications.
Preferred
- Knowledge of autologous cell therapy manufacturing and analytical workflows.
Application Instructions
- Visit https://www.cabalettabio.com/join-our-crew to learn more and apply.
- Develop, implement, and maintain the laboratory validation program supporting Research, Translational Medicine, Manufacturing Sciences & Technology, Analytical/Process Development, and other lab functions.
- Provide strategic and operational leadership for qualification and validation of laboratory instruments/equipment, computerized systems, and supporting infrastructure to ensure FDA/EMA/ICH/GxP compliance for BLA submission and commercial launch.
- Establish a sustainable, risk-based validation lifecycle for advanced therapies and autologous cell therapy products; ensure validated systems generate reliable, attributable, inspection-ready data.
Primary Responsibilities
Validation Program Leadership
- Develop/execute validation roadmap from clinical-stage development through BLA and commercial launch.
- Establish governance; develop validation policies/procedures/standards/templates; build scalable validation framework; drive continuous improvement.
Equipment and Instrument Qualification
- Lead IQ/OQ/PQ, requalification, and decommissioning; ensure documentation is scientifically justified and risk-based; define strategies based on intended use, patient safety, and data integrity risk.
Computerized Systems Validation (CSV)
- Validate LIMS, ELN, instrument software, scientific applications, and data acquisition systems; ensure compliance with 21 CFR Part 11, Annex 11, ALCOA+ and GAMP 5; manage lifecycle/updates with IT and system owners.
Inspection Readiness & Quality Systems
- Create inspection-ready documentation for FDA audits; ensure packages are complete/traceable; serve as SME; lead remediation.
- Integrate with Quality Management System; review/approve key validation documents; support change control; investigate deviations; monitor metrics.
Cross-Functional Leadership & Vendor/People Leadership
- Partner with QA/QC, R&D, IT, and external labs; provide validation expertise for expansion/tech transfer/automation; assess validation impact of new technologies.
- Oversee vendor deliverables; build/mentor validation organization.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Computer Science, Pharmaceutical Sciences, or related.
- 12+ years in biotech/pharma/cell therapy/gene therapy/biologics; 5+ years leading validation organizations.
- Experience supporting BLA/NDA or commercial biologics submissions.
- Experience establishing validation programs in rapidly growing orgs; positive FDA inspection experience.
- Strong knowledge of advanced therapy laboratory operations.
Technical Expertise (Extensive Knowledge Of)
- IQ/OQ/PQ; CSV; risk-based validation; GAMP 5; 21 CFR Parts 11, 210, 211, 600 series; 21 CFR Part 58 (as applicable); ICH Q9/Q10; FDA data integrity guidance; EU GMP Annex 11; ALCOA+; validation lifecycle management; lab automation; analytical instrumentation.
Experience With
- Flow cytometry platforms, cell counting instruments, PCR/qPCR, bioanalytical instrumentation, laboratory information systems, scientific software applications.
Preferred
- Knowledge of autologous cell therapy manufacturing and analytical workflows.
Application Instructions
- Visit https://www.cabalettabio.com/join-our-crew to learn more and apply.