<p>PRODUCT CHEMIST I</p> <p>Job Summary:</p> <p>This position is primarily responsible for the laboratory testing of in-process, release and stability samples for commercial drug products.</p> <p>Responsibilities:</p> <p>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 requirements</p> <p>Testing performed to include basic lab equipment and procedures, such as pH, Assay by HPLC, and Dissolution</p> <p>Document all laboratory testing and maintain accurate and legible notebooks and records</p> <p>Peer review of data, reports, and notebooks</p> <p>Education/Qualifications:</p> <p>BS Degree in Chemistry or related field</p> <p>AS Degree in Chemistry or related field and a minimum of 2 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment</p> <p>BS Degree in non-science field and a minimum of 4 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment</p> <p>Knowledge of cGMP, USP/NF, and FDA guidelines and regulations</p> <p>Experience in analytical methods and lab instrumentation (e.g. HPLC, GC, dissolution, wet chemistry)</p> <p>Excellent oral and written communication skills</p> <p>Strong organization and time management skills</p> <p>Demonstrated ability to work as part of a cross-functional team</p> <p>Working knowledge of Microsoft Word and Excel</p> <p>Experience with software associated with a Laboratory Information Management System (LIMS) and a Chromatography Data System (CDS)</p> <p>Work mainly performed in lab</p> <p>Travel < 5%</p>