Senior Manager, Biologics Analytics

Job Summary

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