Develop and validate robust analytical methods for various aspects of peptide and complex injectable formulations, including :Purity determinationIdentity confirmationQuantification of degradation productsStability assessmentDemonstrate expertise in relevant analytical techniques, including :High-Performance Liquid Chromatography (HPLC)Liquid Chromatography-Mass Spectrometry (LC-MS)Ultraviolet-Visible (UV / Vis) SpectrophotometryGas Chromatography (GC)Particle size analysisIn vitro release testingPerform 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 Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).Possess exposure to characterization studies for peptide and complex injectable formulations as per product-specific regulatory guidelines.Skills Required
analytical method validation , peptides, Formulation