James McGarrigle

About James McGarrigle

Serves as the Chief Operating Officer (COO) of CellTrans Inc, a biotechnology company involved in the development, manufacture, and commercialization of FDA-approved cellular therapies and novel bioengineered technologies for therapeutic treatment of diabetes and other endocrine disorders. Oversees the management of CellTrans operational processes, including all areas of manufacture of human islet cells within a cGMP manufacture facility to ensure the final cell product is produced to the highest acceptable standards of functionality and quality. Identifies continuous process improvement areas to develop scalable, cGMP-compliant processes for manufacturing with a high degree of effectiveness and efficiency. Provides strategic direction, tactical oversight and technical expertise for all activities within the product/process development and manufacturing areas. Provides leadership, resources in establishing and maintaining the quality system to ensure compliance with state and federal regulations. Ensures staff are appropriately trained in current company practices and procedures and delegates responsibilities to ensure staff members grow as capable participants. Lead in all interactions with the FDA regarding the application for a Biologics License for islet cell therapy for brittle type 1 diabetic patients. Oversees internal and external audits from agencies such as the FDA. Coordinates and develops interactions between manufacturing and clinical personnel. Assists in compiling the company\'s budget, and employ strategies to safeguard assets and stock. Prior to CellTrans, served as Assistant Research Professor at the University of Illinois at Chicago, in the Department of Surgery, where led several rodent and non-human primate research studies to evaluate various cell therapies and biomaterial products to combat diabetes, as well as research projects aimed to improve and better assess human islet manufacture and transplantation. Active member of the ISPE (International Society for Pharmaceutical Engineering), an organization dedicated to continuous development of manufacturing, and served in numerous leadership roles including on the Board of Directors at CellTrans. Earned bachelor’s degree in Microbiology and Biochemistry and a PhD in Microbiology, both from the National University of Ireland, Galway. PhD dissertation focused on the toxicity of the sulphur containing amino acid, homocysteine, on Escherichia coli with possible links to human disease.

Experience

1. Chief Operating Officer

   Celltrans Inc

   Aug 2020 — Present · Chicago, IL, US

Education

• National University of Ireland, Galway

  Bachelor of Science - BS

  2001 — 2005

• National University of Ireland, Galway

  Doctor of Philosophy - PhD

  2005 — 2010