Principal Scientist, Analytical Development

Job Summary

A company is looking for a Principal Scientist, Analytical Development - Drug Substance.

Key Responsibilities

• Lead the development and optimization of analytical methods for drug substances using various techniques
• Design and oversee method validation activities to ensure compliance with regulatory guidelines
• Prepare and review technical documents and support regulatory submissions as an analytical expert

Required Qualifications

• PhD in Chemistry or related field with 5+ years of experience; or M.S. with 7+ years; or B.S. with 10+ years of relevant experience
• Experience in analytical development within the pharmaceutical or biotechnology industry
• Direct experience with regulatory submissions and GMP/GLP environments
• Proficiency in chromatographic and spectroscopic analytical techniques
• Comprehensive understanding of ICH, FDA, and EMA guidelines relevant to method development