Maneesha Altekar is a Sr. Technical Manager for Product Robustness & Analytics in Manufacturing Science & Technology at AstraZeneca, currently involved in the development of a holistic robustness framework within AZ Operations. Prior to this role, she supported AZ Operations sites in the Americas Region. Before that, she worked in R&D at AstraZeneca, supporting non-clinical and pre-clinical studies in Neuroscience Discovery and Safety Assessment. She is also involved in the implementation of the Validation Lifecycle Approach at AZ, and is leading an ISPE team to develop a concept paper for PV in packaging. Prior to working for AstraZeneca, Maneesha spent 2 years at GSK supporting Assay Development and High Throughput Screening, and 18 years working in the Chemical industry, providing statistical support to R&D, manufacturing and other functions. She has presented at various conferences including the ISPE PV and PV Statistics conference, ASA Joint Statistical Meetings, ASQ Quality Congress, Lab Automation Conference and Society for Biomolecular Screening, and published several papers. She holds a Ph. D. in Statistics from the University of Delaware.