Alena Tipnis

Alena Tipnis is a seasoned professional in regulatory intelligence and compliance, currently serving as Sr. Manager at AGC Biologics since May 2021. Prior to this role, Alena worked at Boulder iQ and Boulder Sterilization as a Regulatory Engineer, where responsibilities included authoring Emergency Use Authorizations, coordinating regulatory meetings, and supporting quality management systems. Previous experience also includes positions as Operations Engineer at Pfizer and Hospira, focusing on API manufacturing processes, process improvement, and quality systems management. Alena began their career with a research assistantship at Colorado School of Mines and has also interned at Amgen in inflammation discovery. Alena holds a Bachelor of Science in Chemical and Biochemical Engineering from Colorado School of Mines and a Juris Doctor degree from the University of Oregon School of Law.