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