Description Summary This position is primarily responsible for the laboratory testing of raw materials, packaging materials, in-process, release and stability samples for pre-commercial drug products, including the evaluation of new raw materials, new packaging materials, reference standard qualifications, method transfers, and method validations within the framework of cGMP compliance guidelines. Responsibilities • Perform routine and non-routine physical and chemical tests and assays on raw materials, API’s, in-process, finished products, experimental batches and associated stability studies • Testing performed to include basic and complex lab equipment and procedures, such as pH, Loss on Drying, Residue on Ignition, Water Content by Karl Fischer, Assay/Impurities by HPLC, Dissolution, Residual Solvents by GC, and wet chemistry techniques such as titrations and sample derivatizations • Execute method transfer/validation protocols for basic analytical test methods for drug substance/product assay/dissolution/ residual solvents according to ICH/FDA/USP requirements under minimal supervision • Draft method transfer/validation reports for basic analytical test methods for drug substance/product assay/dissolution according to ICH/FDA/USP requirements under minimal supervision • Develop and validate analytical Cleaning Validation methods and perform testing of cleaning validation samples and generate analytical report with supervision. • Document all laboratory testing and maintain accurate and legible notebooks and records • Provide regular update progress reports of projects • Comply with all relevant regulatory requirements • At all times strive to maintain the self-esteem of individual team members and the professionalism of the group as a whole • Perform laboratory troubleshooting, propose solutions and implement • Other projects and duties as required or assigned Experience • BS Degree in Chemistry or related field and 2 - 4 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment Requirements Skills • Experience working in the pharmaceutical industry and/or analytical laboratory is preferred • Knowledge of cGMP, USP/NF, and FDA guidelines and regulations • Expertise in analytical methods and lab instrumentation (e.g. HPLC, GC, dissolution, wet chemistry) • Excellent oral and written communication skills • Strong organization, time management, leadership and troubleshooting skills • Demonstrated ability to work as part of a cross-functional team • Basic knowledge in Microsoft Word and Excel • Experience with software associated with a Laboratory Information Management System (LIMS) and a Chromatography Data System (CDS)