Job Details

A company is looking for a Principal Scientist (AD/Director level), Drug Substance Development focused within CMC.Key ResponsibilitiesAct as the drug substance subject matter expert and manage external drug substance development activitiesSupport technology transfer for manufacturing of clinical supplies and late-stage development activitiesDevelop, review, and approve technical reports and controlled GMP documentationRequired QualificationsMS/Ph.D. degree in Organic Chemistry5 - 10 years of hands-on experience in small-molecule drug substance development and commercializationStrong technical background in developing and scaling up small molecule drug substancesThorough knowledge of cGMP and regulatory requirementsExperience with Quality by Design (QbD) principles and Design of Experiments (DoE) in drug substance development