Associate Director, Analytical Development

Job Summary

A company is looking for an Associate Director, Small Molecule Analytical Development.

Key Responsibilities

• Lead and oversee method development and optimization for drug substances and products at CDMOs
• Design and validate analytical methods, ensuring compliance with ICH and regulatory guidelines
• Collaborate cross-functionally to resolve technical issues and ensure compliance with regulations

Required Qualifications

• BS or MS in Analytical Sciences, Chemistry, or related field with 12 years of experience, or PhD with 7 years of experience in the biopharmaceutical industry
• Direct experience in small molecule method development, validations, and implementations in a GMP environment
• Prior experience overseeing external manufacturing and analytical sites
• Expertise in chromatographic and spectroscopic analytical techniques
• Deep knowledge of the drug development lifecycle and regulatory requirements