Associate Principal Scientist, Regulatory CMC, Synthetic Moities of ADCs & Bioconjugates

Associate Principal Scientist position leading Chemistry, Manufacturing, and Controls (CMC) regulatory strategy for antibody-drug conjugates and bioconjugates. Responsible for executing global regulatory submissions, managing synthetic moieties compliance, and cross-functional collaboration throughout product development and post-approval lifecycle.

Responsibilities

• Lead regulatory CMC strategy for synthetic moieties in assigned ADC and bioconjugate programs
• Develop phase-appropriate global regulatory strategies addressing drug-linkers, payloads, and chemically synthesized components
• Prepare and execute CMC documentation for IND, BLA, MAA, and post-approval submissions including agency responses
• Integrate regulatory strategies across targeting components, conjugation processes, and final drug products
• Manage change controls and collaborate with cross-functional teams to ensure compliance and scientific excellence

Requirements

• Bachelor's degree in chemistry, chemical engineering, biochemistry, or related science field; advanced degree preferred
• At least 10 years pharmaceutical CMC or development experience (5 years with advanced degree)
• Experience in process chemistry, analytical development, manufacturing, quality, or CMC product development
• Demonstrated ability to critically review scientific data and assess technical arguments for clarity and support
• Superior oral and written communication skills with ability to explain complex regulatory issues concisely
• Strong project management, leadership, and stakeholder negotiation capabilities
• Experience with ADCs, drug-linkers, payloads, peptides, or bioconjugate products preferred