Director/Senior Director, Analytical Services (Separations & External Laboratories)

Role: Lead technical and operational oversight of external laboratories supporting commercial biologics, focusing on separations assays for mAbs. Responsibilities: ensure assay robustness, evaluate vendor performance, troubleshoot complex issues, and drive corrective actions; build and maintain strong vendor partnerships; communicate technical, quality, and regulatory matters effectively; support regulatory submissions and investigations. Requirements: 15+ years industry experience, deep expertise in separations for biologics (especially mAbs), proven success managing CDMOs/CROs, and strong communication skills. HighValue: extensive biologics experience with commercial-stage products, GMP analytical testing, regulatory support, and vendor performance management. WorkSetup: travel required; full-time U.S. based, no visa sponsorship.