Principal Scientist Drug Substance

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