Director of Bioanalytical Sciences

📋 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.