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Mark Feild


A co-founder for Product Quality Alliance, Mark Feild, holds a Ph.D. from North Carolina State University in biochemistry and has over 30 years of experience in analytical development, product characterization, product stability, and validation studies throughout the entire product lifecycle.  Involvement with products includes monoclonal antibodies, fusion proteins, biosimilars, vaccines, gene therapy products (virus-like particles), and cell therapy-type products. An accomplished department director responsible for leading the development, commercialization, and analytical control strategies for numerous bio-pharmaceutical products. Proven leadership, skilled in setting strategic analytical goals for Quality Control, Analytical Development, and Research.

In 2005, Mark co-founded WindRose Analytica, Inc., a contract development and testing laboratory providing services for analytical program lifecycle development, conducting method development, method and instrument qualification, validation, stability studies and QC testing. Windrose was acquired by Althea Technologies, Inc. in 2009, where Mark continued working through 2014 before co-founding Product Quality Alliance, LLC.

At Product Quality Alliance, Mark provided consulting services for assisting in devising analytical development strategies, QC testing, Stability Studies, and coordinating with GMP manufacturing of pharmaceutical and biopharmaceutical products, cellular and gene therapy products. He has extensive CMC experience in product development from early stage through commercialization and beyond. His experience includes supporting companies that are challenged with managing the “Cost of Quality”, helping to reduce failures, defects, and rework.

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