Research Associate : Pharma Research Injectable

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

Competencies