America's Job Portal
Position Summary
We are seeking a highly motivated CMC focused Analytical Scientist with deep expertise in analytical method development, qualification, and validation, and a strong foundation in Quality Control to support antibody-drug conjugate (ADC) programs. This role will lead the design, execution, and lifecycle management of robust analytical methods to ensure product quality, support process development, and enable IND and clinical-stage programs.
This role requires demonstrated expertise in ADC-specific analytical challenges, including drug-to-antibody ration (DAR), aggregation, free payload quantification, and stability-indicating methods. Experience supporting CMC regulatory filings, assay control strategies, and management experience with external vendors is essential. A strong understanding of phase-appropriate analytical requirements and readiness for GMP environments is expected.
Key Responsibilit...