Manager, Analytical Development

📋 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