Contract development and manufacturing organization (CDMO), Particle Sciences, has appointed Karen Bossert as vice president of operations as part of its ongoing strategy to grow and enhance its manufacturing capabilities.
 
Bossert’s role will be key to developing and expanding Particle Sciences’ clinical trial and commercial drug manufacturing services following the recent launch of its 5,000 sq. ft commercial drug product manufacturing facility at its site in Bethlehem, PA, which is also home to its drug development operations. She brings three decades of experience in pharmaceutical manufacturing operations to the organization, specializing in aseptic processing, lyophilization and commercial scale operations. Bossert previously held roles as vice president for Lyophilization Technology Inc., quality assurance and operations director for Regeneron Pharmaceuticals and commercial manufacturing manager for Smithkline Beecham Pharmaceuticals.
 
Barbara Morgan, general manager, Particle Sciences, said, “It’s a pleasure to welcome Karen on board at this exciting time for our business as our new commercial facility becomes fully operational, driving growth in our commercial manufacturing capabilities as well as expanding our offering in the clinical trial manufacturing space. Karen will oversee the operations of the engineering team and the clinical trial and commercial manufacturing groups. With her vast industry experience, she will be key to bringing the same standard of excellence associated with our complex formulation development work into our commercial drug product manufacturing offering.”
 
Particle Sciences has also continued to invest in equipment and software by purchasing a dedicated pre-filled syringe filler for both clinical and commercial manufacturing and purchasing and validating a Waters NuGenesis Laboratory and Secure Data Management System to further enhance the compliance of laboratory systems. The new facility was built to accommodate the production of complex sterile and non-sterile finished drugs, such as injectables and lyophilized drugs. It forms part of a wider investment by Lubrizol LifeSciences to strengthen its key capabilities, focusing on new product solutions, capacity expansion and additional commercial manufacturing.