NMR Analyst - ARD

Key Responsibilities

• Perform NMR routine analysis, quantification by NMR and structural elucidation of unknown impurities.
• Prepare and verify impurity characterization data and Certificates of Analysis (COAs) for accuracy.
• Respond to technical queries related to structural elucidation.
• Conduct identification and quantification analysis of plant-related substances by NMR as per Spec & STP, with complete documentation.
• Perform 2D-NMR experiments, solid-state NMR, and multinuclear identification/ quantification analyses.
• Prepare Reference Standard (RS) manuals and provide timely support for project TTD (Technology Transfer Dossier) release.
• Provide accurate and complete characterization documentation to support regulatory filings for drug substances and drug products.
• Ensure timely calibration of NMR instruments in the lab, Liquid Nitrogen filling.
• Ensure compliance with laboratory safety protocols.
• Carry out all NMR lab activities in accordance with cGMP guidelines.

Skill Set Required

• Hands-on experience in operating and troubleshooting NMR instruments (e.g., Bruker)
• Strong expertise in structural elucidation of unknown impurities and degradation products
• Proficiency in 1D and 2D NMR techniques (COSY, HSQC, HMBC, NOESY, TOCSY etc.)
• Working knowledge of solid-state NMR and multinuclear analysis.
• Sound understanding of GLP, GMP, and regulatory documentation requirements.
• Experience in preparing impurity characterization reports, COAs, and RS manuals.
• Knowledge on instrument calibration, qualification (IQ/OQ/PQ), and maintenance protocols.
• Familiarity with pharmacopeial (USP/EP/IP) and STP-based testing methods
• Ability to support regulatory filings (DMF) with accurate characterization data
• Strong analytical, documentation, and report-writing skills.
• Good communication skills for cross-functional query resolution.
• Working knowledge of NMR data processing software (e.g., TopSpin, MDrive, MNova).