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

Role: Associate Principal Scientist in Regulatory CMC for biologics, focusing on antibody-drug conjugates (ADCs) and bio-conjugates, with responsibilities spanning global regulatory strategy development, CMC documentation, and lifecycle management. Responsibilities include serving as a regulatory lead for synthetic moieties of ADCs, developing phase-appropriate strategies, ensuring compliance with global guidelines, managing submission preparation (IND, BLA, MAA, post-approval changes), and collaborating cross-functionally to align regulatory content and milestones. Qualifications: B.S. in Chemistry, Chemical Engineering, Biochemistry or related, with at least 10 years of relevant experience in pharmaceutical CMC, including process chemistry, analytical development, and manufacturing—preferably in small molecules, biologics, or conjugates. Advanced degrees are favored. Skills required include regulatory assessment, dossier preparation, global compliance, and leadership. Preferred qualifications include experience with pre- and post-approval submissions, bio-conjugates, and external partner coordination. High-value specifics: biologics, ADCs, drug-linker chemistry, global regulatory environment, lifecycle management, and GxP adherence. Work setup: hybrid in the US, with no travel required.