Mandy possesses extensive expertise in CMC development across various modalities, ranging from Biologics to mRNA vaccines and Cell Therapy. Notably, she demonstrated exceptional leadership skills as she successfully led CMC team in preparing and submitting the BLA for Abecma, leading to the launch of the groundbreaking Multiple Myeloma CAR-T commercial product in 2021. Currently, Mandy assumes a pivotal role in leading the Product & Analytical Development for Cell therapy programs at BMS.
In her present capacity, she spearheads a team responsible for defining product Critical Quality Attributes (CQAs) through innovative correlative analysis, devising and implementing phase-appropriate analytical development and execution strategies for product control. The team’s comprehensive support spans from preclinical stages to commercial operation, ensuring the seamless progression of Cell Therapy programs. Her team also dedicated significant efforts on automation to improve speed of product release.
Prior to her involvement in the field of cell therapy, Mandy dedicated significant efforts to advance mRNA technology via non-viral delivery tools for vaccine development. Additionally, she amassed extensive experience in biologics development, specifically in CMC analytical development and control strategy.