Senior Manager, Analytical Development

Job Summary

Providing strategic oversight and technical expertise, the full-time Senior Manager, Analytical Development will manage analytical activities at third-party laboratories, focusing on method development, regulatory support, and analytical data provision for small molecules in a remote setting.

Key responsibilities

• Lead analytical activities including method development, optimization, and transfer for synthetic small molecules at contract testing labs
• Collaborate cross-functionally to resolve complex technical issues and ensure compliance with regulations while meeting project timelines
• Manage pharmaceutical stability studies and author technical reports and CMC sections in regulatory documents

Required qualifications

• Bachelor's or master's degree in analytical science, chemistry, or related field with 10 years of experience, or a Ph.D. with 5 years of experience in a GXP environment
• Strong knowledge of the drug development lifecycle, regulatory requirements, and quality standards
• Experience in analytical laboratory testing of pharmaceuticals and related materials
• Proficiency in MS Office, especially Excel, and experience in data review
• Excellent oral and written communication skills