Irving Ford is currently the Head of CAR T QC Laboratories at Celgene. Prior to joining Celgene, Irving was a significant contributor for activities supporting the commercial approval of Novartis’ CAR T product Kymriah®.
Irving has over 28 years of QA/QC experience in the pharmaceutical/biotechnology and cell and gene therapies industries including, but not limited to, non-sterile, sterile, and low bioburden manufacturing production. Irving has designed, implemented and managed paperless laboratories.
Irving has a successful track record working with laboratory, facilities, validation, manufacturing, regulatory, QA, R&D, and compliance personnel to manage and resolve complex quality and manufacturing issues.
Irving has served as the subject matter expert during numerous contract service provider audits as well as for regulatory inspections/filings. Irving was also involved in a successful consent decree remediation.
Irving is an active member of PDA and recently served on the planning committee for the 2018 PDA Global Conference on Pharmaceutical Microbiology. Irving is also a co-author/contributor for the PDA’s TR for EM of Low Bioburden Facilities.
Currently, Irving is working on a task force for creating an ISO Standard for the apheresis collection. Irving is also co-authoring a White Paper for appropriate microbiological controls for ATMPs manufacturing.