Analytical Chemist Job

Analytical Chemist is needed to perform the following duties:

• Scientifically analyze and test raw materials, in-process and finished product samples using advanced analytical instruments like TOC, HPLC, GCMS, GC-FID, LCMS, Dissolution, UV-Vis, IR, KF Titrator, Potentiometry etc. under close supervision of experienced chemists/scientists. Will apply knowledge of broad variety of quality control and analytical techniques;
• Follow guidance from experienced chemists/scientists and assist them in developing and implementing validation protocols and test procedures by performing lab experiments, chemical analysis of materials, preparing test solutions, conducting QC tests etc. to ensure products meet with appropriate regulatory agency validation requirements, custom company standards and industry current practices;
• Compile data for documentation of test procedures and prepare detailed technical/scientific reports;
• Perform analytical method validations as instructed to validate new methods by performing various validation parameters such as precision, specificity, accuracy, linearity, limit of detection and limit of quantitation of the pharmaceutical compounds;
• Calibrate/check critical laboratory equipment and analytical instrumentation and assist in drafting/updating inspection procedures and checklists as necessary;
• Evaluate working standards assigned by department head against reference standards for pharmacopia and non-pharmacopia products by conducting analytical lab tests under guidance from experienced team members;
• Test drug substances, intermediates and raw materials by performing forced degradation studies and chemical analysis/tests while conducting impurity profiles for drug substances and intermediates as per guidelines and instructional training provided by experienced chemists/scientists;
• Assist scientists and work under their direction to develop, implement and maintain quality control systems and activities by collecting/researching scientific data/reports, recording scientific evidence/results from lab/development activities etc.; and
• Approximately 85% of the time will be spent in scientifically analyzing raw materials, chemical compounds, in-process/finished product samples and validating results using modern quality control and analytical methods under close supervision and guidance of experienced chemists/scientists. Approximately 15% of the time will involve assisting in preparing scientific/technical reports/papers and assisting/interacting with scientists and maintaining ICH guidelines and US FDA regulations.

Bachelor’s degree is required in Pharmacy or Pharmaceutics or Chemistry or Pharmaceutical Science.