Thomas Warren

Senior Director of Quality Assurance

Thomas Warren serves as a Manufacturing Operations Leader with more than seven years of biotechnology manufacturing experience across large-scale pharmaceutical organizations. He brings deep expertise in cell culture manufacturing, regulatory compliance, quality systems management, and production leadership within cGMP-regulated environments.

Thomas previously held leadership roles at Boehringer Ingelheim and Amgen, where he managed day-to-day biologics manufacturing operations supporting commercial drug supply. As Manager of Cell Culture Manufacturing at Boehringer Ingelheim, he supervised up to six direct reports, oversaw production scheduling, led troubleshooting initiatives, and coordinated cross-functional efforts to ensure uninterrupted drug supply. During his tenure, the site successfully completed an FDA inspection with zero Form 483 observations.

Throughout his career, Thomas has owned deviations and change controls, served as a manufacturing subject matter expert for inventory systems (MES/SAP), and acted as a key point of contact during regulatory audits and facility transitions. He has extensive hands-on experience with upstream cell culture processes, bioreactor preparation, media batching, harvest operations, tangential flow filtration, and environmental monitoring within Class 100 cleanroom environments.

At Amgen, Thomas advanced through progressive manufacturing roles, serving as shift lead and technical trainer while maintaining 100% batch success through disciplined process oversight and team coordination. He has contributed to facility fit assessments for new products, equipment commissioning, safety risk mitigation strategies, and the development of performance metrics to improve operational efficiency.

Thomas holds a Bachelor of Science from the University of California Los Angeles, graduating with honors. He is also a member of the Golden Key National Honor Society and earned the rank of Eagle Scout.