Principal Scientist Drug Substance

Job Summary

A company is looking for a Principal Scientist (AD/Director level), Drug Substance Development focused within CMC.

Key Responsibilities

• Act as the drug substance subject matter expert and manage external drug substance development activities
• Support technology transfer for manufacturing of clinical supplies and late-stage development activities
• Develop, review, and approve technical reports and controlled GMP documentation

Required Qualifications

• MS/Ph.D. degree in Organic Chemistry
• 5 - 10 years of hands-on experience in small-molecule drug substance development and commercialization
• Strong technical background in developing and scaling up small molecule drug substances
• Thorough knowledge of cGMP and regulatory requirements
• Experience with Quality by Design (QbD) principles and Design of Experiments (DoE) in drug substance development