Principal Scientist Analytical Development & Quality Control, Small Molecule

📋 Description

• Lead analytical strategy for drug substance and product in small molecule program.
• Oversee outsourced QC and characterization methods (development, validation, release).
• Support formulation development using analytical data (solubility, dissolution, stability).
• Identify analytical/regulatory risks early; drive remediation with QA/CMC/Regulatory.
• Author regulatory submissions' analytical sections (Module 3).
• Provide UPLC-based support for research activities (analogue characterization, progression decisions).

🎯 Requirements

• 7+ years in small molecule analytical development in regulated pharma.
• Phase-appropriate analytical control strategy: specs, stability, impurity control, validation, regulatory docs.
• Experience developing, validating, transferring analytical methods for drug substance/product release and stability.
• Experience coordinating CDMOs/CROs for analytics development, validation, release testing, investigations.
• Hands-on UPLC/HPLC method development and troubleshooting.
• Self-starter in lean environments; clear cross-functional communicator.
• Advanced degree in analytical chemistry or related field, or equivalent experience.

🎁 Benefits

• Equity in the company
• Medical, dental, and vision insurance
• 401(k) with 4% matching
• Flexible time off
• Paid parental leave
• Annual learning and development stipend
• Daily Retro-sponsored lunch and snacks