Analytical Chemist Job

Analytical Chemist to perform the following duties:

• Develop, validate and conduct inter-laboratory transfer of analytical methods for active pharmaceutical ingredients and dosage forms under supervision of experienced chemists/scientists;
• Develop, improve & validate analytical methods periodically and perform validation & quality control activities in a group setting under guidance form experienced chemists/scientists;
• Assist senior chemists/scientists draft laboratory standard operating procedures (SOPs) for review by analytical department managers;
• Design, evaluate and monitor stability programs for drug products by following established guidelines and as instructed/guided by QC/analytical team managers;
• Evaluate working standards and reference standards for pharmacopial and non-pharmacopial products by conducting laboratory tests and stress studies in a group setting along with experienced scientists;
• Test drug substances, intermediates and raw materials by performing forced degradation studies and chemical analysis/tests as instructed while conducting impurity profiles for drug substances and intermediates – will be performed under close guidance from more experienced QC/analytical team members;
• Work with advanced analytical equipment like HPLC, GC, DSC and IR and apply knowledge of broad variety of analytical techniques;
• Assist QC/analytical managers to prepare scientific documents for submission to the US FDA by researching & analyzing, as instructed, ICH guidelines/USFDA regulations applicable to manufacturing of pharmaceutical products; and
• Approximately 85% of the time will be spent in developing, improving and validating analytical methods for active pharmaceutical ingredients/ dosage forms, testing drug substances and performing quality control activities, all under supervision of experienced chemists/scientists in our QC/analytical team and while following established guidelines. Approximately 15% of the time will involve preparing technical reports/papers and conferring/interacting with scientists and maintaining ICH guidelines and US FDA regulations.

Bachelor’s degree is required in Chemistry or Pharmaceutical Science