Associate Director, Quality Control and Tech Ops
T2 Biosystems develops a medical diagnostic platform that enables rapid and accurate diagnostic tests of all types on a single instrument.
Biotechnology professional currently serving as the Senior Director of Operations at T2 Biosystems, an emerging in vitro diagnostics company dedicated to savings lives and reducing healthcare costs associated with early detection of sepsis. Throughout an over 15 year career in the Medical Device, and Biotechnology industries I have demonstrated excellence in the following: • Process Development/Improvement, Scale Up, Characterization, and Validation • Test Method Development/Improvement, and Validation • New Product Introduction and Technology Transfer • Product Life Cycle Management • Leading projects with cross functional departments • Experience with change order process, and developing SOPs, WIs, BRs, BOMs, SPECs • Experience with quality system process ownership inclusive of NCRs, Deviations, and CAPAs • Implementation of lean manufacturing principles • Development of COGS models, and consistent execution of cost reduction projects • Effective leadership, with over 8 years of experience in building, coaching, and developing teams
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