Job Description
📋 Description Remote with 30% travel anticipated Lead development and tracking of stage-appropriate testing for drug substance and product Coordinate with Analytical, CMC, QA, Regulatory, Project Management and CRO/CMO partners Review SOPs, test methods, specifications, method transfers, COAs and stability summaries Support site investigations for OOS/OOT and deviations 🎯 Requirements MS in Organic Chemistry, Analytical Chemistry or Pharmaceutical Science 5+ years in CRO or pharma/biotech environments Experience in analytical assay development, impurity and in-vitro dissolution release Proficiency with HPLC and physicochemical properties (solubility, solid state, physicochemical Knowledge of cGMP, USP/EP/JP guidelines; familiarity with FDA/EMA/ICH guidance 🎁 Benefits Market-leading compensation 401(k) with employer match Employee Stock Purchase Program (ESPP) Pre-tax commuter benefits (transit/parking) Fertility & family-forming benefits Flexible, “take-what-you-need” PTO and paid holidays
