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Greenville, NC, United States, 2014/10/21 - With more than 25 years of pharmaceutical industry experience, Lewis brings to his role expertise in new chemical entity development, API and dosage form manufacturing, generic drug development and contract services.
Mayne Pharma has appointed Q. Dwight Lewis as vice president of quality for its operations in the United States.
Lewis is responsible for managing all quality-related functions to ensure that Mayne Pharma’s U.S. pharmaceutical operations which range from laboratories to manufacturing lines continue to comply with global regulatory agency and industry standards.
“Drug product integrity doesn’t occur spontaneously; it is the result of thoughtfully considered and deliberately executed quality standards and operations,” said Stefan Cross, president of Mayne Pharma’s U.S. operations. “Dwight’s knowledge and expertise in quality compliance and assurance will support Mayne Pharma’s ability to deliver superior pharmaceutical services and products to our clients and the patients we collectively serve.”
Before joining Mayne Pharma, Lewis was senior director of quality for Teva Pharmaceuticals, where he managed quality assurance and control functions for solid dose manufacturing. Prior to that, he served as vice president of quality for Irix Pharmaceuticals, and as director of quality operations for DSM Pharmaceuticals.
Lewis brings to his new role expertise in new chemical entity (NCE) development, active pharmaceutical ingredient (API) and solid dose form manufacturing, generic product development, and contract services. He holds a bachelor’s degree in chemistry from the University of North Carolina at Chapel Hill.
About Mayne Pharma
Mayne Pharma is a publicly traded specialty pharmaceutical company listed on the Australian Securities Exchange. The company develops and manufactures branded and generic product globally either directly or through distribution partners while applying its drug-delivery expertise for contract development and manufacturing services.
Mayne Pharma has a 30-year track record of innovation and success in developing new oral drug delivery systems, and these technologies have been successfully commercialized in numerous products that have been marketed around the world.
Mayne Pharma has drug development and manufacturing facilities in Salisbury, Australia, with expertise in formulating complex oral dose forms, including controlled substances, modified release products and inherently unstable compounds.
In the United States, Mayne Pharma’s operations consist of two main business segments: The first Metrics Contract Services focuses on contract pharmaceutical services; the other develops and manufactures branded and generic pharmaceutical products.
Through Metrics Contract Services, the company offers pharmaceutical development and manufacturing services to clients worldwide. Areas of expertise include pharmaceutical formulation development; first-time-in-man formulations; clinical trial materials manufacturing for Phase I, II, and III trials; and analytical method development and validation services leading to commercial-scale manufacturing. Capabilities include highly potent, cytotoxic and unstable compounds; Schedule II-V controlled substances; and products with poor bioequivalence, for which Mayne Pharma offers a vast portfolio of drug delivery methods.
To learn more about Metrics Contract Services and Mayne Pharma, visit us online.