Director of Analytical Development
Location: Remote
Compensation: Salary
Reviewed: Wed, Apr 02, 2025
This job expires in: 18 days
Job Summary
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
COMPLETE JOB DESCRIPTION
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