PRODUCT CHEMIST I
Job Summary:
This position is primarily responsible for the laboratory testing of in-process, release and stability samples for commercial drug products.
Responsibilities:
Perform accurate and timely analysis of 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, Assay by HPLC, and DissolutionDocument all laboratory testing and maintain accurate and legible notebooks and recordsPeer review of data, reports, and notebooks
Education/Qualifications:
BS Degree in Chemistry or related fieldAS Degree in Chemistry or related field and a minimum of 2 years of pharmaceutical product analysis experience in a cGMP-regulated lab environmentBS Degree in non-science field and a minimum of 4 years of pharmaceutical product analysis experience in a cGMP-regulated lab environmentKnowledge of cGMP, USP/NF, and FDA guidelines and regulationsExperience in analytical methods and lab instrumentation (e.g. HPLC, GC, 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)Work mainly performed in labTravel < 5%
