As part of OsoBio’s quality control department, the microbiology and chemistry laboratories that Larese now directs are responsible for environmental monitoring, analytical method development, and testing all incoming raw materials, components, and in-process and finished products involved in the company’s cGMP sterile manufacturing operations.
“Kathleen provides direction and organization to functions that help ensure the continuous quality of the sterile injectable drugs we manufacture as well as the safety of the patients who rely upon them,” said Milton Boyer, president of OsoBio. “Managing a team of highly capable scientists fiercely committed to data integrity, Kathleen will drive operational excellence and deliver distinct value to our clients.”
Larese brings to OsoBio more than 10 years of management experience in laboratory operations responsible for regulatory compliance, project documentation, quality assurance, inventory management and waste disposal. Most recently, she was senior technical staff member at Sandia National Laboratories, where she used her black belt certification in Lean and Six Sigma to reduce waste and optimize operations.
Larese holds a master’s degree in business administration from the University of New Mexico Anderson School of Business, and is finishing her master’s degree in biomedical science from the university’s School of Medicine. She completed a graduate fellowship in nuclear and radiochemistry at San Jose State University, and holds an American Chemical Society-certified bachelor’s degree in chemistry from Western Washington University.
A member of the Parenteral Drug Association, Larese is a member of the American Chemical Society and past president of the Albuquerque chapter of Executive Women International.
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. Our company offers significant knowledge and experience in late-phase clinical products and successfully taking them to commercialization.
In the history of our 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.