Ketan Gujarathi works at Bristol-Myers Squibb as Manager, Metrics & Knowledge Management. Ketan is responsible for the collection and reporting of quality metrics internally as well as externally. In addition, Ketan is leading efforts to develop processes and tools that facilitate proactive discussion of performance metrics and provide visibility/transparency to drive continuous improvement, prioritization and focus resources. He has been working with the ISPE on compiling the industry response to the FDA Metrics guidance.
Ketan, Lean Six Sigma certified as well as an ASQ Certified Quality Engineer, has over 5 years of experience in the biotech, pharmaceutical, and medical device industries. Most recently, Ketan was the Quality Engineering Manager at Temptime Corporation, developer and manufacturer of vaccine vial temperature monitoring devices. Prior to that Ketan spent 4 years with Catalent Pharma Solutions where he held roles of increasing responsibility across manufacturing, process engineering, and quality functions specializing in process improvements and lean manufacturing.
Ketan holds a BS degree in Biomedical Engineering from the New Jersey Institute of Technology.