Senior Scientist, Regulatory Affairs- CMC - Synthetic Moieties of ADC's and Bioconjugates

Senior Scientist role leading regulatory chemistry, manufacturing, and control strategy for synthetic components of antibody-drug conjugates and bioconjugates. Responsible for delivering regulatory milestones across product development and post-approval lifecycle while managing cross-functional collaboration.

Responsibilities

• Lead regulatory CMC strategy for synthetic moieties of assigned ADC and bioconjugate programs
• Develop and execute phase-appropriate global regulatory CMC strategies for drug components
• Manage CMC documentation for IND applications, BLAs, MAAs, and post-approval submissions
• Integrate synthetic-moiety regulatory strategy with targeting component and conjugation process
• Conduct regulatory risk assessments and manage change controls with compliance focus

Requirements

• Bachelor's degree in Chemistry, Chemical Engineering, Biochemistry, or related science field
• Minimum 5 years regulatory CMC or pharmaceutical development experience in small molecules or synthesized modalities
• Experience in process chemistry, analytical development, manufacturing, quality, or technical operations
• Expertise in regulatory CMC, chemistry, and analytical methods
• Strong regulatory compliance, document coordination, and communication skills
• Preferred: CMC regulatory submission support and health authority interaction experience
• Preferred: Experience with drug-linkers, payloads, ADCs, peptides, or bioconjugate products

Compensation: $117,000–$184,200 base