Assistant Cmc Technical Writer Jobs in New York

Identification, selection and management of CDMOs for process development, process optimization, GxP manufacturing and analytical activities for drug-substance and drug-product

Direct experience working with FDA, including knowledge of current ICH guidelines

In depth understanding of modern process development, solid state characterization, hands on cGMP manufacturing and CDMO management

Establish and manage all CMC internal and external activities related to process development, manufacturing and validation for our programs

Ph.D. in Chemistry or related discipline with at least 15+ years of industrial experience in Process Chemistry and Drug Development

Strong track record of drug discovery experience, success, and leadership, exemplified by advancement of programs through multiple stages of development