at Medefil, Inc. in Glendale Heights, Illinois, United States
Job Description
Medefil Inc. seeks full-time Analytical Scientist in Glendale Heights, IL. Lead analytical development of parenteral formulations in a product development environment. Act as a Subject Matter Expert for chromatograph techniques such as HPLC, GC, TLC, IC, LC-MS, and GC-MS. Lead different wet chemistry testing. Responsible for leading all analytical aspects of a project while working with other functional areas to advance projects through the pipeline. Lead API and finished product related method development, optimization, validation, and release and stability testing. Independently set up and operate lab equipment, conduct instrument and analytical method troubleshooting; research and recommend corrective actions for out-of-specification and out-of-trend results. Responsible for all aspects of Analytical Development and Validation including transfer to Quality Control or other testing laboratory. Evaluate thoroughly DMF for different APIs for completion of analytical methods and lead discussions with API manufacturers to evaluate analytical method package. Support corporate quality and continuous improvement process. Write protocols, methods, standard operation procedures, and submission documents independently. Design experimental studies and write reports. Review CRO work to ensure corporate quality is maintained and activities are performed on timely manner. Maintain through knowledge of ICH conditions, USP method development, validation, and verification requirements. Accurately records experimental procedures, test results, and observations to meet GMP requirements. Maintain experimental records, procedures to meet cGMP requirements. Participate in the review process for appropriate department SOPs, study protocols, and reports. Participate in the training of incoming laboratory staff. Participate as needed in departmental efforts directed toward equipment maintenance, calibration, and qualification. Author various sections in Chemistry, Manufacturing and Control (CMC) document for Regulatory submission.
Email resume to sandeep.aggarwal@medefilinc.com to apply.
