I am a seasoned professional with a passion for transitioning biologics companies and biological products from clinical to commercial manufacturing. With an extensive background in transforming labs with little or no GxP experience into fully documented, qualified, and compliant environments. I excel in implementing cutting-edge Plant 4.0 concepts. My expertise lies in creating paperless labs through the integration of Electronic Lab Notebooks (ELN), Laboratory Information Management Systems (LIMS), and digital method execution systems (LES). I am adept at guiding organizations through the transition to paperless manufacturing execution systems (MES), complemented by equipment monitoring systems (EMS), building automation systems (BAS), and advanced process controls (PCS and PLC).I thrive on achieving successful outcomes within tight timelines, and I take pride in extending my ownership to include accountability for the entire IT department. If your focus is on biologics, operations, and digital transformation, I am the person you need to drive your success.
Listed skills include Gmp, Validation, Pharmaceutical Industry, Computer System Validation, and 36 others.