Senior Scientist, Drug Product

Role: Process Development Senior Scientist specializing in biologics drug product process characterization and optimization. Responsibilities: lead studies on late-stage drug product processes supporting BLA and commercial readiness; develop stable formulations; author protocols, reports, and SOPs; serve as subject matter expert for GMP manufacturing, evaluate change controls, deviations, and drive process improvements through technological innovation; support regulatory filings and participate in audits. Requirements: Bachelor’s degree in relevant field, with 2+ years in biologics process development; experience with frozen liquid and lyophilized formulations; strong organizational and communication skills; ability to work cross-functionally. High-Value: biologics, drug product process development, GMP, process validation, formulation development, regulatory support, cross-functional collaboration. WorkSetup: on-site in Framingham, with some travel.