All Requirements Masters degree in Pharmaceutics, Analytical Chemistry, or a closely related field or foreign equivalent degree, plus 8 years of experience in small molecule drug substance and drug product analytical pharmaceutical development. In the alternative, will accept Ph.D. and 5 years as described. Experience, which may be gained concurrently, must includebr 5 years of handson experience providing advanced skills in technologies for pharmaceutical analysis HPLC and UPLC with UVVis, QDa, RID, and CAD detectors; MS, FTIR, GCHS, UVVis, KF, Dissolution with fiber optics UV detection, PSD, SEM, TOC for development and validation of analytical methods for new drug substances and drug products.br 5 years of experience authoring and executing method validation protocols and reports, for APIs, IPCs, raw materials, nonAPIs and cleanout samples, establishing specifications for new drug substances and drug products and authoring analytical regulatory sections, applying knowledge of regulatory requirements and guidelines cGMP, ICH, FDA, and USP consistent to the stage of pharmaceutical development.br 5 years of handson experience in analytical software packages Empower, openlab chemstation, Malvern, TIAMO, ASAP Prime, Fusion QbD, ELN, and Cirrus GPC.br 5 years of experience working crossfunctionally with formulation, process development, chemical development, QA, QC, and Regulatory groups and providing analytical expertise to progress drug substance and drug product development.
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