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Chemist – Senior Research Scientist – Analytical Research and Development – Pharmaceuticals
  • Perform analytical method development, method validation and method transfer
  • Strong knowledge on the forced degradation studies and data interpretation
  • Support formulation development by developing and validating suitable analytical test methods, with a focus on dissolution, HPLC and GC methods
  • Perform characterization of the R&D formulations and provide analytical support for studies necessary for chemistry and manufacturing controls, mentor junior scientists as needed
  • Draft test methods, specifications, method validation protocols and reports as per the Company SOPs and regulatory guidelines
  • Draft various Drug Product Risk Assessment Reports per regulatory requirement
  • Coordinate with the departments of product development, QC, QA, regulatory affairs and manufacturing for regulatory submissions
  • substances and finished products
  • Must have advanced degree in Analytical Chemistry or other related fields
  • At least 7-10 years of R&D experience in pharmaceutical industry
  • Must have good background in analytical method development and validation for drug
  • Good understanding of guidelines for product development, and good GMP compliance.