Senior Manager, Biologics Analytics

To support biologics development from IND-enabling studies through BLA submission and commercialization, the full-time Senior Manager, Biologics Analytics will execute and support data-driven integration, analysis, and interpretation of CMC data while working remotely. Key Responsibilities Execute and support the integration, analysis, visualization, and interpretation of CMC data across various development stages Aggregate and trend analytical, process, stability, and comparability datasets to inform CMC decision-making and regulatory strategies Translate complex CMC datasets into clear conclusions for internal governance and regulatory submissions Required Qualifications M.S. in Analytical Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Engineering, or a related discipline 8 - 10 years of experience supporting IND and BLA submissions, with direct involvement in data presentation and regulatory narratives Strong understanding of analytical methods and data types used in biologics CMC Experience with statistical analysis, data trending, and visualization in a regulated environment Solid knowledge of regulatory expectations for CMC data integrity and lifecycle management