Analytical Chemist Job

Analytical Chemist is needed to perform the following duties:

• Perform development, validations and/or inter laboratory transfer of analytical methods for active pharmaceutical ingredients and dosage forms under close supervision and guidance of senior chemists/scientists;
• Assist scientists in developing, improving & validating analytical methods and performing validation and quality control activities in a group setting under direction of experienced chemists/scientists;
• Assist in drafting laboratory standard operating procedures (SOPs) by researching new regulatory guidance and cGMP and prepare reports for senior chemists/scientists and department heads to review & approve;
• Design, evaluate and monitor stability programs by conducting laboratory tests/stress studies for drug products in a group setting by following established stability plans & instructions provided by experienced analytical team members;
• 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;
• Work with advanced analytical equipment like HPLC, GC, DSC and IR and apply knowledge of broad variety of analytical techniques;
• Research and study ICH guidelines and USFDA regulations in manufacturing of pharmaceutical products and assist scientists by gathering/updating scientific data from lab tests/analysis to prepare and review documents for submissions to the US FDA; and
• Approximately 85% of the time will be spent in developing, improving and validating analytical methods for active pharmaceutical ingredients and dosage forms while testing drug substances, and performing quality control activities – all under close supervision and guidance of experienced analytical team members. Approximately 15% of the time will involve assisting in preparing 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