Develop and validate robust analytical methods for various aspects of peptide and complex injectable formulations, including:
Purity determination
Identity confirmation
Quantification of degradation products
Stability assessment
Demonstrate expertise in relevant analytical techniques, including:
High-Performance Liquid Chromatography (HPLC)
Liquid Chromatography-Mass Spectrometry (LC-MS)
Ultraviolet-Visible (UV/Vis) Spectrophotometry
Gas Chromatography (GC)
Particle size analysis
In vitro release testing
Perform thorough data analysis and interpretation, prepare comprehensive analytical protocols and reports, and contribute to regulatory submissions.
Proactively identify and resolve analytical issues, ensuring the accuracy, reliability, and robustness of developed methods.
Ensure strict compliance with current Positive Manufacturing Practices (cGMP) and Positive Laboratory Practices (GLP).
Possess exposure to characterization studies for peptide and complex injectable formulations as per product-specific regulatory guidelines.

📌 Senior Research Scientist Analytical Development Vadodara
🏢 Alembic Pharmaceuticals
📍 Vadodara