Job Description
📋 Description Define and execute bioanalytical strategy for biologics across discovery to clinical. Lead ligand-binding assays (ELISA, MSD, ECL) and flow cytometry for PK/PD. Direct DMPK and bioanalytical studies, integrating PK/PD for candidate selection. CRO partnerships: select, onboard, and manage external labs; review protocols. Author bioanalytical sections of IND/IB/study reports; ensure GLP and ICH M10. Establish assay qualification frameworks and lifecycle management; cross-functional alignment. 🎯 Requirements PhD in immunology, biochemistry, pharmacology, analytical chemistry, bioengineering, or related life-science. More than 10 years biotech/pharmaceutical industry experience in bioanalytical or DMPK development for biologics. Deep expertise in bioanalytical method development, qualification, and validation for large molecules across human and preclinical species (NHP and rodent). Demonstrated hands-on and strategic experience with PK, PD, and receptor occupancy assays, and with DMPK study design and interpretation. Strong, proven track record of partnering with and managing CROs to deliver regulated bioanalytical data — a must. Working knowledge of GLP and regulatory bioanalytical guidance (FDA, EMA, ICH M10). 🎁 Benefits Open, flexible, and friendly work environment. Summary of Benefits available. Opportunity to contribute to AI-enabled biologics programs.
