Employee Responsibilities:Executes drug product development and commercialization studies, new product introduction and process validation at the commercial site. Designs and executers process characterization activities. Ensures appropriate design principles including DOE are used where applicable. Authors protocols for studies, ensures appropriate design of experiment and sample size selections. Responsible for sample submissions and tracking. Employs statistical tools and methods to analyze results. Authors technical reports that can be used as a source of documentation for regulatory filing. Also writes or performs second-person review for high-quality CMC sections for regulatory submissions. 
