How a Helium Manufacturing Release Test Increases

Monica Cardona is a senior program manager for single-use and integrated systems at Merck. She has worked in life sciences for more than 20 years. She has had several global roles in technical, strategic, and operational marketing. She currently works cross-functionally with quality, Emprove®, regulatory, operations, R&D, and commercial teams, to create and implement product portfolio enhancement programs that differentiate product offering, improve customer satisfaction and drive portfolio growth. Monica holds a B.S. in biology from Hofstra University and an M.S in biology from Adelphi University. She has published and lectured internationally on a wide range of filtration, validation, and single-use bioprocessing topics. Monica is a member of the Parenteral Drug Association (PDA), BioPhorum, and a founding member of Bio-Process Systems Alliance (BPSA).

Chuck Raye has 14 years of experience in the bioprocessing industry, designing, validating, and managing single-use (SU) components and systems. He has also supported operational teams in the manufacturing of SU systems. In his current role, he works directly with customers, R&D, and operations to develop solutions that advance SU technology in the fill finish processes of sterile filtration and filling. Chuck holds a B.S. in mechanical engineering from Syracuse University.