Duane has over 20 years of process development experience in the BioPharmaceutical industry. He received his Ph.D. in Biochemistry from the University of Wisconsin in 1987 purifying and characterizing oxygen-sensitive metalloenzymes. After starting his career at Synergen, he spent 6 years at Genetics Institute developing, licensing, and supporting commercial production of recombinant Factor IX. He has been at Amgen’s Longmont Colorado site for 13 years. He is currently a Scientific Director supporting process characterization and regulatory filings for commercial and late stage development projects. He has contributed to the evolution of QbD at Amgen, and was a key player in Amgen’s efforts in the FDA QbD pilot program.