About this role
Job Description Expertise in: Analytical method development and validation for dissolution/in-vitro release using USP Type I, II, IV, shaking water bath, bottle rotating apparatus, or other suitable techniques. Particle size distribution and Zeta potential (Mastersizer/Zetasizer), Viscosity (Rheometer/Brookfield), Assay and degradation product/content testing, including preservative and antioxidant analysis for complex injectables (Including Suspensions, Emulsion, Microsphere and LAI). Reverse engineering of complex injectables (Including Suspensions, Emulsion, Microsphere and LAI) and other injectable products. Analytical method development for admixture and dilution studies in line with the product information leaflet (PIL) for injectable products. Responsible for: Routine and stability sample analysis of complex injectables and other injectable products. Extensive literature search for fast method development. Excipient evaluation for complex injectables and other injectable products. Method equivalency assessment and analytical method transfer to QC in compliance with quality and ethical standards for injectable products. Addressing FDA queries within the stipulated timelines. Interpreting analytical data from R&D and plant stability studies and communicating findings to relevant stakeholders. Operating and calibrating analytical instruments as required. Managing day-to-day analytical laboratory activities in accordance with GLP/GMP guidelines. Maintaining the work area in compliance with GLP, GMP, and safety guidelines Work Experience 7 to 9 years Education Masters in Pharmaceutical Chemistry or Analytical Chemistry Doctorate in Pharmaceutical Chemistry or Analytical Chemistry Competencies