Assoc Research Scientist 556

• This position acts as Planner to work with project teams through data collection, identifying key attributes and defining parameters to meet stability operations with relation to GMP, quality, manufacturing, FDA and other influential guidelines and regulations.
• Responsible for the design of GMP stability studies used to establish expiration dating for new product development.
• Responsible for performing stability data trend reviews of stability studies in support of new and commercial product development.
• Responsible for writing regulatory reports that justify proposed expiration dating for new products.
• Participates in laboratory investigations as author of technical evaluations that characterize the stability trending of suspect data.
• Technical consultant to manufacturing and research personnel in providing stability assessment and requirements for product enhancements/changes.