Accessibility & LanguageQuality Assurance & Project Manager
Technology Services Directorate, University of Galway
James Gilmore specialised in regenerative medicine and advanced therapeutics with expertise spanning stem cell biology, translational research, GMP manufacturing, quality assurance and process development. James holds a B.Sc. in Undenominated Science and an M.Sc. in Regenerative Medicine from the University of Galway.
James subsequently worked as a Research Assistant at the Regenerative Medicine Institute under Dr. Aideen Ryan, investigating the impact of low-dose chemotherapeutic agents on multiple myeloma, with a strong focus on flow cytometry-based analysis.
From 2020 to 2026, James held progressive roles at HiTech Health, including Technologist, Manufacturing Lead, and Head of Production. James was instrumental in establishing process development laboratories and implementing a Quality Management System, from standard operating procedures to equipment lifecycle, change control, deviation and corrective and preventative action management.
James’ technical scope includes cell manufacturing and expansion (MSCs, iPSCs, CAR-NK, keratinocytes, & more), cryopreservation, transfection, bioreactor processing, and GLP-standard assay development including flow cytometry-based assays, nucleic acid gels, spectrophotometry, and particle characterization (size, concentration, and zeta potential), rapid sterility, mycoplasma and endotoxin testing.
James was heavily involved in the development of ATMP cleanroom facilities achieving EU GMP certification. James implemented the sterile gowning, manual material transfer and aseptic processes at the facility. James contributed to business development through client engagement and proposal generation.
