Director of Analytical Development

A company is looking for a Sr. Director/Executive Director, Analytical Development. Key Responsibilities Lead analytical development and commercial quality control groups for late-stage small molecule programs Author and revise analytical development sections of regulatory submissions and contribute to CMC regulatory strategy Oversee analytical method transfers, method development, and validation for drug substance and drug product Required Qualifications, Training, and Education Ph.D./M.S. in life sciences, ideally Chemistry or Analytical Chemistry, with 10+ years of relevant experience; B.S. with 5 additional years will be considered Proven leadership and personnel management skills Knowledge and experience with CMC analytical requirements for IND and NDA/MAA filings Experience managing external CDMO relationships Familiarity with various analytical techniques and regulatory areas

Apr 3, 2025 - 01:27

A company is looking for a Sr. Director/Executive Director, Analytical Development. Key Responsibilities Lead analytical development and commercial quality control groups for late-stage small molecule programs Author and revise analytical development sections of regulatory submissions and contribute to CMC regulatory strategy Oversee analytical method transfers, method development, and validation for drug substance and drug product Required Qualifications, Training, and Education Ph.D./M.S. in life sciences, ideally Chemistry or Analytical Chemistry, with 10+ years of relevant experience; B.S. with 5 additional years will be considered Proven leadership and personnel management skills Knowledge and experience with CMC analytical requirements for IND and NDA/MAA filings Experience managing external CDMO relationships Familiarity with various analytical techniques and regulatory areas