Scientist III/Team Leader performs as the analytical lead for active formulations’ development for pharmaceutical use. Performs chromatographic method development and troubleshooting as well as phase-based method validation in a GMP environment. Uses in-depth Analytical/Instrumentation Skills, ICH, FDA, CDER and other regulatory guidance documents in designing and executing technical studies. Exhibits a good understanding of potential drug-inactive ingredients’ interactions, potential degradation pathways of the active ingredient and analytical skills to design unique experiments to support specialized formulation development. The Team Leader will provide technical leadership and management for a team of scientists and chemists in support of drug development activities under GLP and CGMP regulations. Provides troubleshooting advice based on job holder’s expert laboratory skills.
Bachelor’s or Master’s degree in pharmacy, chemistry or related scientific field with extensive experience in a semi-solid analytical laboratory environment or equivalent experience, or PhD degree in Chemistry or related scientific field with exposure to topical pharmaceutical analytical development and topical drug delivery in the individual’s educational background.