ASSOCIATE PRINCIPAL SCIENTIST REGULATORY CMC - BIOLOGICS (R4)-SYNTHETIC MOIETIES (DRUG-LINKER) OF AD

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 Integrating regulatory strategies across product components Assessing global requirements 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 Experience with drug-linkers ADCs Peptides Oligonucleotides External partner collaboration 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. #J-18808-Ljbffr Merck