Vice President Of Technical Operations
Develop and execute a road map of CMC activities from phase 1 to NDA submission and product launch. Implement best practices for the pre-formulation characterization and formulation development of sterile products, including liquid/lyophilized products and suspensions. Provide robust support for clinical programs for a variety of products (small molecules, biologics, AAV vectors) by developing and producing drug substances and drug products. Lead and manage multiple functions, including manufacturing and quality control for drug substances and drug products. Provide regulatory writing support. Lead selection and qualification of suppliers for drug substances, drug products and raw materials. Negotiate supply agreements.