Lead projects or act as a subject matter expert (SME) under minimal supervision focused on the late-stage and commercial development, validation, and optimization of analytical methods
Manages, oversees, helps design and review method transfer, method development, and validation of release and stability-indicating methods
Mentors and trains others on a wide variety of analytical techniques
Troubleshoots and optimizes analytical methods for the characterization of drug products
Designs qualification/validation and bridging/comparability studies for product characterization
Conducts data analytics, including retrospective data collection and statistical analyses
Communicates results both internally and externally through oral and written updates

BS, MS, or PhD in physical, chemical, biological, or pharmaceutical science
BS plus eight (8) years of experience, or MS plus six (6) years of experience, or PhD plus three (3) years of experience
Experience with analytical development and qualification/validation of biologics, especially live viral products
Experience with late-Phase and commercial bio-analytics
Knowledge of OFAT, DOE, and other study design methodologies including experience with statistical analyses

Senior Manager, Analytical Development

Key skills