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Albuquerque, NM, United States, 2013/05/08 - Lee is responsible for overseeing all quality-related functions to ensure the company’s continued compliance with Current Good Manufacturing Practices (cGMP), including quality systems, quality control and manufacturing quality assurance - OsoBio.com.
OsoBio has appointed David M. Lee vice president of quality.
Lee is responsible for overseeing all quality-related functions to ensure the company’s continued compliance with Current Good Manufacturing Practices (cGMP), including quality systems, quality control and manufacturing quality assurance.
Lee brings to his role more than 20 years of professional experience managing quality operations and API and sterile manufacturing.
Prior to joining OsoBio in June 2012, Lee served as director of validation and quality at Amgen Inc., where, among other responsibilities, he managed all validation activities for a $1.2-billion site expansion. During his time at Amgen, he also managed production operations for two of the company’s signature chemotherapy drugs, NEUPOGEN® and Neulasta.®
“David’s knowledge and expertise in quality operations will support OsoBio’s ongoing ability to deliver exceptional sterile pharmaceutical manufacturing products and service,” said Milton Boyer, president of OsoBio. “David has already proven to be a great asset to the OsoBio team and the clients we serve.”
Lee holds a master’s degree in biology from California State University, Northridge, and a bachelor’s degree in biology from the University of California, Riverside. He is a member of the Parenteral Drug Association.
OSO BioPharmaceuticals Manufacturing, LLC (osobio.com) is a contract manufacturing organization (CMO) that specializes in delivering injectable sterile liquid, suspension and lyophilized biologic and pharmaceutical products to the pharmaceutical industry. The company offers significant knowledge and experience in late-phase clinical products and successfully taking them to commercialization.
In the history of its Albuquerque, N.M., facility, OsoBio has manufactured more than 250 distinct commercial presentations in every major therapeutic category. The U.S. Drug Enforcement Administration (DEA) has granted OsoBio registrations for Schedule II through V controlled substances.