An Analytical Chemist studies the chemical components of materials in a mixture or sample, to identify the components and quantify them. May work to develop new pharmaceutical products or provide quality control or toxicology testing for products.
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
Requirements:
Experience BS Degree in Chemistry or related field and 2 - 4 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment 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)
