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

Role: Lead bioassay technical oversight for biologics, focusing on monoclonal antibody potency assays supporting commercial biologics at TG Therapeutics. Responsibilities: serve as an expert in biologics bioassays, evaluate and troubleshoot assay performance, and ensure assay robustness; manage external laboratory relationships, monitor vendor performance, and drive improvements; communicate complex scientific, quality, and regulatory issues to stakeholders; author regulatory and technical documentation supporting submissions and inspections; collaborate across functions to ensure compliance and assay validity. Requirements: 15+ years in biopharmaceuticals with deep expertise in bioassays, especially monoclonal antibody potency; proven success managing external CROs/CDMOs; strong communication skills; experience supporting regulatory filings, GMP analytical testing, and investigations; advanced degree in Biochemistry, Biological Sciences, or related field; willingness to travel internationally. HighValue: biologics, monoclonal antibodies, cell therapy potency, bioassay expertise, vendor management, GMP compliance, regulatory support, commercial-stage biologics, FDA/EMA submissions. WorkSetup: full-time, U.S.-based; international travel necessary.