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Samone Guillaume

@samoneguillaume

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I lead MSAT commercialization, tech transfers, and validation strategy for CAR-T and viral vector therapies.

United States

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What I'm looking for

I'm looking to lead commercialization, technology transfer, validation, and process-improvement efforts for cell and gene therapy manufacturing programs in a cross-functional, quality-focused environment.

I lead MSAT strategy for late-stage and commercial CAR-T programs at Minaris Advanced Therapies, guiding PPQ, APV, EMPQ, CCIT, pilot runs, and commercialization for major pharmaceutical clients.

I've led technology transfers, process characterization, validation planning, control strategies, and GMP documentation while partnering with Process Development, QA, Engineering, Manufacturing, and global clients. I also drove CSV remediation across 135 GxP systems, preventing $1.9M in loss through structured Kaizen events.

My background spans CAR-T cell processing at Novartis, virology study direction, and aseptic vaccine filling at Sanofi Pasteur. I bring hands-on experience building compliant, scalable manufacturing operations and representing MSAT strategy during FDA and client inspections.

Experience

Work history, roles, and key accomplishments

Senior MSAT Engineer I

Minaris Advanced Therapies

Feb 2023 - Sep 2026 (3 years 7 months)

Led MSAT strategy for late-stage and commercial CAR-T programs, overseeing PPQ, APV, EMPQ, CCIT, and pilot runs. Managed technology transfers, authored validation plans, and led CSV remediation for 135 GxP systems.

MSAT CAR T Therapies PPQ APV EMPQ CCIT Technology Transfer CSV Veeva MES Risk Assessment GMP FDA Inspections

Scientist, Virology Study Director

Minaris Advanced Therapies

Jul 2021 - Feb 2023 (1 year 7 months)

Served as Study Director for release-relevant virology assays supporting cell and gene therapy programs, ensuring GLP/GMP compliance and data integrity. Led assay development, validation, and technical transfer packages.

Virology Assay Development Validation Technical Transfer GLP GMP Data Integrity Mentorship

Cell Processing Specialist II – CAR-T Cell Therapy

Novartis

Mar 2020 - Jul 2021 (1 year 4 months)

Operated processes for commercial CAR-T therapies, overseeing patient-specific cell processing from Day 0 through Harvest. Analyzed flow cytometry data to assess CAR-T cell viability and functionality.

CAR T Therapies Cell Processing Flow Cytometry Viral Vector GMP SOP Development

Senior Biological Technician

Sanofi Pasteur

Jul 2018 - Mar 2020 (1 year 8 months)

Supervised aseptic vaccine filling and environmental monitoring operations within ISO 5/7/8 cleanrooms. Executed process verifications, deviation investigations, and CAPA actions to maintain GMP compliance.

Aseptic Filling Environmental Monitoring GMP CAPA Deviations and Investigations Trackwise Autoclave Validation