Overview
The Sr Biopharma Scientist supports verification and validation activities for molecular diagnostic products to be used in investigational studies that are subject to domestic and international regulatory requirements, e.g., US FDA, Japan PMDA, EU IVDD/IVDR and clinical laboratory regulations for the Biopharma business unit. This position is primarily responsible for developing and executing comprehensive and strategic assay analytical validation plans based on alignment with regulatory agency expectations. The role requires productive cross-functional collaborations with multiple Myriad Genetics teams (e.g., R&D, Operations, Regulatory Affairs, Quality Assurance, Software and Information Technology, Laboratory Directors) and external stakeholders (e.g., pharmaceutical partners… Click here to view original post
