Janet Perez-Brown Bristol-Myers Squibb

Janet Perez-Brown has been with Bristol-Myers Squibb since 2006.  Since joining the Analytical Strategy and Operations Microbiology group in 2008 Janet was one of the principle participants that developed methodology in response to questions from the FDA regarding microbial hold time and Container Closure Integrity studies for parenteral drug products. She has been responsible for numerous instrument qualifications and re-qualifications. In 2019, she became a member of the Microbiology Center of Excellence, and is working to identify new, automated microbiological test methods, assisting BMS sites with investigations, and providing feedback to health authority questions. She works closely with manufacturing, overseeing the bioburden testing of raw materials and in process materials for parenteral manufacturing.  Janet interacts with Analytical Project Team Leaders, formulators and manufacturing engineers to assure that appropriate samples are taken and dealt with, as well as overseeing the outsourcing of testing. Janet has been responsible for working with the stability groups to develop, validate and transfer microbial limits tests for a number of products.