Key Responsibilities:**
- **Analytical Method Development:** Develop and optimize analytical methods for the characterization of pharmaceutical raw materials, intermediates, and finished products.
- **Method Validation:** Conduct method validation studies in accordance with regulatory guidelines and internal procedures.
- **Sample Analysis:** Perform routine and non-routine analysis of samples using various analytical techniques (e.g., HPLC, GC, UV-Vis, FTIR, dissolution testing).
- **Documentation:** Prepare and review technical documents, including method development reports, validation protocols, standard operating procedures (SOPs), and regulatory submission documents.
- **Compliance:** Ensure all laboratory activities comply with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and relevant regulatory requirements.
- **Troubleshooting:** Identify and resolve technical issues related to analytical methods and instrumentation.
- **Data Interpretation:** Analyze and interpret analytical data, ensuring accuracy and reliability of results. Prepare detailed reports and presentations of findings.
- **Collaboration:** Work closely with cross-functional teams, including Formulation Development, Quality Assurance, Quality Control, Regulatory Affairs, Manufacturing, Engineering and Supply chain to support product development and commercialization.
- **Laboratory Maintenance:** Maintain laboratory equipment and instrumentation, ensuring they are in good working order. Follow all safety protocols and maintain a clean and organized laboratory environment.
- **Continuous Improvement:** Stay current with industry trends, scientific advancements, and technological innovations to continuously improve analytical methods and practices.
· Any other duties as assigned by supervisor.
#### **Qualifications:**
- **Education:**
- Associate Scientist: Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or related field.
- Scientist: Master’s or Ph.D. in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or related field.
- **Experience:**
- Associate Scientist: 2+ years of experience in analytical method development in the pharmaceutical industry or related field. Fresh graduate will be considered.
- Scientist: 2 - 5 years of experience in analytical method development in the pharmaceutical industry or related field.
