OsoBio has appointed Catherine R. Buck director of manufacturing.
In her capacity, Buck is responsible for ensuring that OsoBio’s operations comply with current Good Manufacturing Practices (cGMP) as they apply to the manufacturing of injectable sterile liquid, suspension and lyophilized pharmaceutical products. In addition, she ensures compliance with appropriate U.S. Food and Drug Administration and Drug Enforcement Administration regulations, and directs manufacturing activities to ensure timely, cost-effective and efficient production.
Buck brings to OsoBio more than 20 years of leadership and project management experience within the pharmaceutical, medical device and construction industries. She has managed multiple commercial and clinical pharmaceutical manufacturing plants that generated up to $2.5 billion annually.
“The same continuous improvement expectations that bear on just about every aspect of industrial productivity exist within pharmaceutical manufacturing as well,” said Milton Boyer, president of OsoBio. “We are fortunate to add someone with Catherine’s breadth of experience to lead a manufacturing team that keeps OsoBio competitive without sacrificing our commitment to quality and cGMP compliance.”
Her experience includes the start up, process, equipment and facility validation of a new Amgen manufacturing plant that produced Epogen, ® that company’s highest revenue product. Her work included successfully obtaining FDA approval of automated equipment and software, and preparing for inspection and successfully obtaining FDA approval for commercial production. Buck also has managed manufacturing facility operations for Johnson & Johnson and Siemens.
Buck holds a bachelor’s of science degree in electrical engineering from Tufts University, and has completed the Emerging Leader Program at Columbia University.
OsoBio specializes in delivering injectable sterile liquid, suspension and lyophilized biologic and pharmaceutical products for the pharmaceutical industry. We offer our clients significant experience and knowledge in late Phase III and commercial products.
In the history of our New Mexico facility, we have produced 250-plus distinct commercial products in every major therapeutic category. The DEA has granted OsoBio registrations for Schedule II-V controlled substances.