Essential Duties and Responsibilities:
The Pharmaceutical Chemist performs set up, calibration, operation, and maintenance of laboratory test equipment. Performs assigned work in a timely and safe manner conforming to regulatory, company, and compendial requirements. Adheres to cGMP, which include, but is not limited to, proper laboratory documentation and maintenance, and archiving of paperwork. Compiles reports of analytical tests, ensuring reports are accurate and complete with documentation of procedures, equipment, and reagents used in analytical testing. Develops proficient practical laboratory skills, a thorough knowledge of chemistry theories, analytical techniques, and adopts site procedures as required. Assists in the execution of protocols, method transfers, and validation studies under the guidance of more experienced analysts. May need training in the handling of controlled substances. The Pharmaceutical Chemist performs routine and non-routine quality control testing of raw materials, in process, residual, finished product, and stability testing within the framework of the site policies and cGMP regulations. Participates in special studies to accomplish company and departmental goals. Records and reports data accurately and incompliance with current methods/SOPs, USP/NF, other compendia as applicable, and cGMP. Performs duties under the guidance of laboratory management or designee.
Education/Experience:
To qualify for a chemist I - Bachelor’s Degree in Chemistry or related science field is required with 2 years of pharmaceutical experience in a professional setting is preferred (university internships do not meet this criteria).
To qualify for a chemist II - Bachelor’s Degree in Chemistry or related science field is required with 4 years of pharmaceutical experience in a professional setting is preferred (university internships do not meet this criteria).
To qualify for a chemist III - Bachelor’s Degree in Chemistry or related science field and 8 years of pharmaceutical experience; or an equivalent combination of education and experience/training; advanced degree in Chemistry or closely related field is desirable, but not required; pharmaceutical laboratory experience is required.