Kyle Carter Email & Phone Number

Kyle Carter is a Director of Quality Control at Kite Pharma at Kite Pharma. He possess expertise in process improvement, gmp, sop, recruiting, project management and 3 more skills.

Listed skills include Process Improvement, Gmp, Sop, Recruiting, and 4 others.

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  Director Quality Control

  Kite Pharma

  Mar 2022 - Present - Frederick, Maryland, United States

  Kite Pharma, Frederick, MD• Head of Analytical Lifecycle Management for the Global Quality Control (QC) organization responsible for the strategic oversight of commercial cell therapy vector and final product analytical testing portfolio that includes flow cytometry, PCR, and ELISA based methods. o Lead a team of QC specialists responsible for laboratory software and instrument alignment, ownership of global Change Controls & Corrective Actions Preventative Actions (CAPAs), method performance monitoring, analyst proficiency assessments, and curation of critical global QC test method documentation.o Sponsor and lead QC cross-functional and cross-site working teams that manage critical new method implementation phases such as validation, comparability, specification generation, transfer, filing readiness, post approval implementation, and jurisdictional control strategies.o Guided team responsible for delivering improved potency and functional CAR test method volatility and operational efficiency with the introduction of a new antigen specific positive target cell line (Raji).o Responsible for driving budget, resource, and stakeholder alignment, leveraging operational and financial business cases, to purse global implementation of new test method automation solutions for % Transduction, mycoplasma, and potency (ELISA) assays.• Global Business Process Owner of the LabVantage Laboratory Information Management System (LIMS)o Develop and oversee strategic implementation of a 21 CFR Part 11 enterprise LIMS across 5 clinical and commerical sites and leveraged by 1500+ users to test viral vector and cell therapy products.o Formed a LIMS center of excellence team dedicated to business operational support while assuring the application meets global and site business requirements for continuous improvement through close coordination with site QC leads and network participants.