Senior / Principal Scientist, Formulation and Drug Product Development

Role: Senior/Principal Scientist leading formulation and drug product development for ADC pipeline, with a focus on late-stage development, process validation, regulatory submissions, and lifecycle management. Responsibilities: develop robust formulations for biologics and ADCs, oversee process development, technology transfer, and process characterization; lead comparability assessments and establish control strategies; collaborate across teams (Manufacturing, QC, Regulatory, Clinical); author and review regulatory and technical documentation; support process validation and lifecycle initiatives; evaluate emerging technologies; mentor junior scientists. Requirements: Ph.D. or Master’s degree in Chemistry, Chemical/Biochemical Engineering, or related field; 5+ years (Ph.D.) or 8+ years (Master’s) biotech/biopharma experience, with proven expertise in biologics/ADC drug product development, lyophilization, process validation, and late-stage programs through Phase 3 and regulatory approval. HighValue: biologics and ADC formulations, lyophilized and liquid dosage forms, late-stage development, process validation, regulatory submissions (IND, BLA), and lifecycle management. WorkSetup: not specified; travel up to 10%, domestic and international.