About the position
The Analytical R&D Chemist will be responsible for developing, validating, and optimizing analytical methods such as assay, related substances, dissolution, and residual solvents for raw and finished products, including injections and ophthalmic ointments. The role involves using methodologies such as HPLC/UPLC, UV/Visible Spectroscopy, GC, and MS. Additionally, the chemist will perform stability and finished product testing for ANDA formulated products using wet chemistry, dissolution (I & II), and KF titrator. The position also includes conducting method transfers of active pharmaceutical ingredients and finished dosage forms, analyzing raw materials, in-process, and finished dosage formulations in accordance with GMP/GLP standards. The chemist will evaluate and investigate out-of-specification test results for pharmaceutical products and implement corrective and preventive actions (CAPA). Furthermore, the role requires the compilation and analysis of test information to determine equipment operating efficiency and troubleshoot technical procedures, methodology, and instrumentation for GC, DSC, and particle size instruments.
Responsibilities
- Develop, validate, and optimize analytical methods for raw and finished products.
- Perform stability and finished product testing for ANDA formulated products.
- Conduct method transfer of active pharmaceutical ingredients and finished dosage forms.
- Analyze raw materials, in-process, and finished dosage formulations as per GMP/GLP.
- Evaluate and investigate out-of-specification test results and implement CAPA.
- Compile and analyze test information to determine equipment operating efficiency.
- Troubleshoot technical procedures, methodology, and instrumentation.
Requirements
- Master's degree in Chemistry, Pharmacy, or Pharmaceutical Science.
- 2 years of experience in the job offered or as a Research Associate in the pharmaceutical industry.
- Working knowledge of HPLC/UPLC, Particle size Analyzer, UV/Visible, Dissolution Apparatus (I & II), and KF Titrator.
