ASSOCIATE PRINCIPAL SCIENTIST REGULATORY CMC - BIOLOGICS (R4)-SYNTHETIC MOIETIES (DRUG-LINKER) OF ADCs AND BIOCONJUGATES

Role: Associate Principal Scientist/Associate Director in Regulatory CMC focusing on biologics conjugates, primarily ADCs and bio-conjugates, with responsibilities spanning global regulatory strategy development, dossier preparation, and lifecycle management for synthetic moieties like drug-linkers. The position involves providing regulatory leadership within cross-functional teams, ensuring compliance with international regulations, and managing submission activities for INDs, BLAs, MAAs, and post-approval changes. Key responsibilities include integrating regulatory strategies across product components, assessing global requirements, and collaborating on scientific and regulatory documentation. Qualifications: B.S. in Chemistry, Chemical Engineering, Biochemistry, or related field; 10+ years' relevant experience including process chemistry, analytical development, manufacturing, or CMC development; demonstrated regulatory expertise in small molecules or chemically synthesized modalities. Preferred skills include experience with drug-linkers, ADCs, peptides, oligonucleotides, external partner collaboration, and global lifecycle management. High-Value: biologics conjugates, ADCs, drug-linkers, regulatory submissions (IND/BLA/MAA), global CMC strategies, post-approval lifecycle, GxP compliance. Work setup: hybrid; no travel required.