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
Qualifications:
- 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.
