The Senior Manager, Analytical Development reports to the Senior Director of QA\QC. The position requires leading the analytical chemistry laboratory through all phases of product development. The position is responsible for managing the analytical evaluation of drug substances, excipients, drug product intermediate, finished drug product, cleaning assay development and stability samples. The Senior Manager will be required to work in development and regulated environments, including adherence to cGMPs, regional and country specific regulations, as well as internal SOPs. The person is a subject matter expert in assay validation according to pertinent regulatory guidelines. The person leads a dynamic team of advanced degree professionals. The person is responsible for managing a group that supports the regulatory requirements for all assays that are required for drug approval (e.g., extractable and leachable studies, assay\impurities, nitrosamine and trace metal assessments, etc).