Karen Steffen

Karen Steffen has worked in the biotechnology industry since 2001. Karen began their career at Dendreon Corporation as an EH&S Program Manager and Sr. Quality Control Analyst. In 2009, they became the Corporate EH&S Manager at Dendreon, where they managed teams engaged in Environmental Health & Safety, Security, Emergency Services, Laboratory Services, and facility engineering. Karen was also responsible for a facility budget of $5.5MM. In 2011, they moved to Omeros Corporation as a Clinical Operations Contractor, where they generated end point data for pivotal clinical trials and tracked DVDs providing visual documentation of cataract surgery procedures. In 2012, they became a Project Analyst, Manufacturing at Omeros Corporation, where they supervised procurement and production for four lines of pharmaceutical products under development, managed all technology transfer activity, and created Standard Operating Procedures, Test Methods, Validation Reports, Batch Records, and Part Number Specifications. In 2014, they became a CMC & Technical Operations Consultant at Heights Biotechnology LLC, providing advice and expert guidance to a small virtual start up seeking to bring a monoclonal antibody (MAB) to the market. Karen also reviewed and drafted regulatory submissions, SOPS, specifications, batch records, and other technical documents, and oversaw the production of 3 to 4 MABs, leading the fill finish efforts for the drug product while conducting audits of manufacturing facilities. In 2015, they took on two roles as a Contract Manufacturing Manager (contract) at Juno Therapeutics and a Contract Manufacturing Project Management at Blaze Bioscience.

Karen Steffen attended the University of Wisconsin-Madison from 1994 to 1998, where they earned a Bachelor of Science in Medical Microbiology & Immunology.