Research Associate : Pharma Research Injectable

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