Director, Analytical Development

Role: Director of Analytical Development leading protein characterization for biopharma pipeline targeting TGF-ß signaling. Responsibilities: develop analytical strategies across early to late-stage biologics (Pre-Clinical to Phase III), oversee method development, validation, and transfer; collaborate with manufacturing, quality, and external CDMOs/CROs to establish phase-appropriate assays; support process development, stability, comparability, and regulatory submissions; mentor scientific team and ensure data quality and compliance. Requirements: MS with 10+ years or PhD with 7+ years in molecular/cellular/structural biology or biochemistry; deep expertise in protein characterization, analytical chemistry, and biophysical methods (e.g., chromatography, spectroscopy, mass spectrometry); experience supporting late-stage biologics (Phase 3, commercialization); strong collaborative skills; proficiency in recombinant protein expression is a plus. High-Value: biologics, fusion proteins, mAbs; analytical support from preclinical through commercial phases; expertise in structural and physicochemical characterization; involvement in regulatory filings (IND, BLA/MAA). WorkSetup: not specified; salary range $200,000–$226,000.