Location Requirement:This role is available in either the U.S. West Coast (ideally around San Diego, CA) or the East Coast (ideally near Raleigh, NC or Boston, MA). The position entails occasional travel between these locations to facilitate cross-site collaboration and operational needs.The CMC & Manufacturing, Science and Technology Drug Substance Lead is a pivotal role responsible for:Serving as an experienced subject matter expert (SME) and process owner for the synthesis of Drug Substance (DS) in small molecules intended for oral dosage forms.Leading technical workstreams for manufacturing process transfers from development to commercial sites, managing scale-up activities, executing process validations, and overseeing the manufacturing of Drug Substance small molecules at external manufacturers for both clinical and commercial projects.Collaborating effectively with external manufacturing partners, managing all technical aspects of drug substance synthesis, including GMP and non-GMP processes.Leading internal activities related to external manufacturing, encompassing process change assessments, major/critical deviations, risk assessments, and CAPAs.Reviewing and supervising the design, setup, execution, and documentation of DS-related technical studies, CMC development, and commercial operations, as well as process and equipment qualifications and validations.Writing and reviewing relevant sections for registration files, variations, and market expansions.Issuing, reviewing, and approving relevant internal and external SOPs, ensuring compliance and correctness of external manufacturing instructions.Contributing to the establishment of new analytical specifications and stability programs, reviewing changes as necessary.Supporting the evaluation and sourcing of new Drug Substance small molecules and oral dosage forms, engaging with alternative contract manufacturers, and participating in developing supply and quality agreements.Staying updated on modern synthetic organic chemistry methodologies and advancements, and introducing new technologies applicable to process innovation, cost reduction, or yield improvement.
Feb 27, 2026