Raw Materials Chemist

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Job Summary: This position is primarily responsible for the laboratory testing of raw materials and packaging materials or in-process, release and stability samples for commercial drug products.Scope of Job: Work on a team of 6 or more analysts. No direct reports. No purchase approval or budget responsibilities.Responsibilities:Perform accurate and timely analysis of raw materials and packaging materials or in-process, release and stability samples for drug products according to current analytical procedures, SOPs, laboratory guidelines and safety requirementsTesting performed to include basic lab equipment and procedures, such as pH, Loss on Drying, Residue on Ignition, Water Content by Karl Fischer, wet chemistry techniques such as titrations, Assay by HPLC, and DissolutionDocument all laboratory testing and maintain accurate and legible notebooks and recordsPeer review of data, reports and notebooksExperience/Education Requirements:BS Degree in Chemistry or related field AS Degree in Chemistry or related field and a minimum of 2 years of pharmaceutical experience in a cGMP-regulated environmentBS Degree in non-science field and a minimum of 4 years of pharmaceutical experience in a cGMP-regulated environmentSpecific Skills:Knowledge of cGMP, USP/NF, and FDA guidelines and regulationsExperience in analytical methods and lab instrumentation (e.g. HPLC, dissolution, wet chemistry)Excellent oral and written communication skillsStrong organization and time management skillsDemonstrated ability to work as part of a cross-functional teamWorking knowledge of Microsoft Word and ExcelExperience with software associated with a Laboratory Information Management System (LIMS) and a Chromatography Data System (CDS)

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