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James Stout, Ph.D.

Vice President, Process Sciences at Natrix Separations


Jim Stout is Vice-President Process Sciences at Natrix Separations.He is responsible for all aspects of process development and science for Natrix hydrogel chromatography membranes, advancements in bioprocess membrane technology, process application development, scale-up and technology transfer, customer field applications, customer technical support and technical marketing. Over the past 20 years, Jim established himself as a downstream process and technology leader in the biopharmaceutical industry.  Jim developed and characterized an improved refolding and recovery process for an E. coli made recombinant ScFv to complement C5 and scaled it from lab bench to 50,000L in cGMP manufacturing (Alexion Pharmaceuticals).  Jim designed a new orthogonal analytical assay using hydrophobic interaction chromatography for assessing the charge variants in Humira®. Jim also assessed and pioneered advancement of the recovery process for Enbrel®, implementing new resins and new filters to streamline the original purification process, and improve throughput and yield. His recent positions include Director of Process Science & Engineering at ImmunoGen; Associate Director of Process Development at Shire HGT; Director, Purification Sciences at Amgen; Group Leader of Purification Process Sciences at the Abbott Bioresearch Center; as well as process development leadership positions at Medarex and Alexion. Jim is also an Adjunct Professor at Providence College in Rhode Island and the University of Rhode Island, teaching general chemistry, organic chemistry, and biochemistry to undergraduate students and continuing education students. Jim earned his Ph.D. in Chemistry (Biochemistry major; Analytical Chemistry minor) at the University of Cincinnati, and was an NIH Post-Doctoral Fellow at the University of Cincinnati, College of Medicine.