Job Details

A company is looking for a Principal Scientist, Analytical Development - Drug Substance.Key ResponsibilitiesLead the development and optimization of analytical methods for drug substances using various techniquesDesign and oversee method validation activities to ensure compliance with regulatory guidelinesPrepare and review technical documents and support regulatory submissions as an analytical expertRequired QualificationsPhD in Chemistry or related field with 5+ years of experience; or M.S. with 7+ years; or B.S. with 10+ years of relevant experienceExperience in analytical development within the pharmaceutical or biotechnology industryDirect experience with regulatory submissions and GMP/GLP environmentsProficiency in chromatographic and spectroscopic analytical techniquesComprehensive understanding of ICH, FDA, and EMA guidelines relevant to method development