Particle Sciences, a Lubrizol LifeSciences company and pharmaceutical contract development and manufacturing organization (CDMO), has announced the appointment of Karen Bossert as vice president of operations as part of its ongoing strategy to grow and enhance its manufacturing capabilities.
Karen’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. She 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, at 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.
Over the last three years Particle Sciences has grown its workforce and will continue to grow the team as it expands and develops its manufacturing capabilities.
For further information, please visit: www.particlesciences.com
About Particle Sciences
Particle Sciences, a Lubrizol LifeSciences company, is an integrated provider of drug development services. Particle Sciences focuses on BCS II/III/IV molecules, biologics and highly potent compounds through a variety of technologies including emulsions, gels, micro and nano-particulates, drug/device combination products, solid solutions and others. Particle Sciences is FDA registered and DEA licensed. Through a full range of formulation, analytic and manufacturing services, Particle Sciences provides pharmaceutical companies with a complete and seamless development solution that minimizes the time and risk between discovery and the clinic. The company was founded in 1991 and is headquartered in Bethlehem, Pennsylvania.
About Lubrizol LifeSciences
Lubrizol LifeSciences is a preferred Contract Development and Manufacturing Organization (CDMO) partner for complex pharmaceuticals and high-end medical devices providing differentiated polymers and excipients, along with state-of-the-art design, development and manufacturing services to the healthcare industry.
About The Lubrizol Corporation
The Lubrizol Corporation, a Berkshire Hathaway company, is a market-driven global company that combines complex, specialty chemicals to optimize the quality, performance and value of customers’ products while reducing their environmental impact. It is a leader at combining market insights with chemistry and application capabilities to deliver valuable solutions to customers in the global transportation, industrial and consumer markets. Lubrizol improves lives by acting as an essential partner in our customers’ success, delivering efficiency, reliability or wellness to their end users. Technologies include lubricant additives for engine oils, driveline and other transportation-related fluids, industrial lubricants, as well as additives for gasoline and diesel fuel. In addition, Lubrizol makes ingredients and additives for home care, personal care and skin care products and specialty materials encompassing polymer and coatings technologies, along with polymer-based pharmaceutical and medical device solutions.
With headquarters in Wickliffe, Ohio, Lubrizol owns and operates manufacturing facilities in 17 countries, as well as sales and technical offices around the world. Founded in 1928, Lubrizol has approximately 8,700 employees worldwide. Revenues for 2017 were $6.3 billion. For more information, visit Lubrizol.com.
