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Senior Research Scientist- Analytical Development

Senior Research Scientist- Analytical Development

ConfidentialVadodara
12 days ago
Job description
  • 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 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

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