| Mary Beth Pelletier is currently the Head of Quality for Biogen’s Gene Therapy Manufacturing facility in Research Triangle Park, NC, USA, where she is building the QA and QC organization to support site start up, commissioning, qualification, and GMP manufacturing of AAV-based gene therapies, as well as leading QC testing strategy and implementation for these programs. Previously, she was the Head of Global QC Analytical Technology, where her team supported optimization, validation, transfer, troubleshooting, and lifecycle maintenance of analytical procedures for Biogen’s biologics and gene therapy portfolio from Phase 1 throughout the commercial lifecycle. Mary Beth is a topic lead for the ICH Expert Working Group for Q2(R2) and Q14 representing BIO. She received a bachelor’s degree in chemistry from Northwestern University in Evanston, IL, a Ph.D. in chemistry from The Scripps Research Institute in La Jolla, CA, and an MBA from North Carolina State University. Prior to Biogen, Mary Beth held positions in biologics formulation and analytical development. |
