Director, Analytical Development

Role Summary

The Director of Analytical Development, reporting to the Senior Director, Analytical Chemistry, drives progress of both early and late-stage molecules by delivering phase-appropriate analytical methods and validation. Leads method innovation, ensures alignment with regulatory expectations, and partners cross-functionally to support process development, formulation, CMC, and quality activities. Role is based in San Francisco or Boston with 10% travel.

Responsibilities

• Oversee analytical method development, qualification, and validation for starting materials, in-process control, process intermediates, drug substances and drug products
• Conduct analytical technical review of method validation/qualification protocols, data and reports generated at CDMOs for drug substances and drug products
• Review and approve analytical reports or certificates of analyses from CDMOs for batch release and stability testing of drug substances...