Analytical Development Research Associate - Injectables

1. Extensive work experience in analytical method development and validation of injectable products.

2. Proven experience with injectable, peptide, and suspension products.

3. Demonstrated expertise in sameness and characterization studies for complex molecules.

4. Proficient understanding of various analytical techniques including HPLC, GC, UV, FTIR, KF, and mass spectrometry.

5. Advanced skills in troubleshooting analytical methods and instruments.

6. Proven experience in method development, validation, transfer, and documentation in compliance with regulatory requirements.

7. Familiarity with Quality by Design (QbD) principles and their application in analytical method development.

8. Experience with stability testing and forced degradation studies for injectable products.

9. Knowledge of current Good Manufacturing Practices (cGMP) and ICH guidelines.

10. Responsible for practicing Good Documentation practice in department.

11. Responsible for ensuring safety in Analytical Laboratory.