Key Responsibilities:
- Lead development, qualification, and execution of bioanalytical methods for degrader antibody conjugates (DACs), including intact conjugates, total antibody, conjugated payload, and released degrader species.
- Design and implement LC-MS/MS workflows (Sciex platforms) for sensitive/selective quantitation of small-molecule payloads, linker-derived species, and catabolites.
- Use high-resolution MS for DAC characterization and metabolite identification.
- Develop hybrid LBAβLC-MS/MS strategies to support conjugate quantitation and differentiation.
- Plan and interpret in vitro studies (plasma/lysosomal stability, linker cleavage kinetics, protease processing, degradation assays).
- Support in vivo PK/tissue distribution/tumor exposure studies to inform exposure-response relationships.
- Characterize DAC biotransformation pathways (linker cleavage products, payload metabolites, antibody modifications).
- Partner with DMPK, Proteomics, Pharmacology, and Chemistry to guide design using stability/exposure/degradation data.
- Author/review technical reports and regulatory documentation; troubleshoot matrix effects, low-level quantitation, and heterogeneity.
- Mentor junior scientists; evaluate emerging technologies; oversee CROs for method development/transfer/qualification.
Preferred Qualifications:
- Experience in targeted protein degradation or heterobifunctional degrader platforms.
- Hybrid LBAβLC-MS/MS and ligand-binding assays (ELISA, MSD).
- Linker chemistry/conjugation and degradation mechanisms knowledge.
- Exposure to FDA/EMA regulatory bioanalytical guidance.
Requirements:
- Ph.D. with 5+ years or M.S. with 8+ years in bioanalysis/analytical chemistry (or related).
- Deep LC-MS/MS bioanalysis expertise (development, qualification/validation, troubleshooting).
- Proven Sciex platform experience (e.g., 7600 ZenoTOF, 6500+, 7500) and high-resolution MS.
- Strong background in ADCs/DACs/bioconjugates; payload quantitation.
- Experience with in vitro ADME and in vivo PK; ability to interpret integrated datasets.
- Sample prep proficiency (e.g., immunocapture, enzymatic digestion, hybrid workflows).
- Strong data analysis/reporting; excellent communication.
Application Instructions:
- Applicants must be legally entitled to work in the US.