Quality by Design
Quality by Design, a new concept in the pharmaceutical industry, creates a road map for designing new chemical and biological compounds so that quality is easily transferable from the pharmaceutical development phase to commercial manufacturing. It is an example of how we are thinking differently and doing things differently at Bristol-Myers Squibb.
We are participating in a pilot on Quality by Design sponsored by the U.S. Food and Drug Administration and have already chosen one of our late-stage development compounds as our pilot project.
Making Quality by Design a reality requires coordination between the pharmaceutical development and the manufacturing groups, and a thorough understanding of the changing global regulatory environment.
That’s where Global Regulatory Sciences and Chemistry Manufacturing and Control (CMC) comes in. We work with scientists in pharmaceutical development and manufacturing to determine how Quality by Design can be applied to the development of our new compounds. Our goal is to provide the best guidance and strategy possible to meet the evolving expectations of global health authorities regarding the chemistry, manufacturing and control content of our marketing authorization applications.
We value regulatory scientists who tend to think “out-of-the-box” in applying regulation and guidance to global CMC development plans. We seek those with a solid background in at least one area of pharmaceutical science, deep experience as a CMC regulatory scientist and a willingness to be part of a multidisciplinary team that has shared accountability for the pharmaceutical development of our products.