16 Sep
|
Apitoria Pharma
|
Hyderabad
16 Sep
Apitoria Pharma
Hyderabad
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
- Solid 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).
📌 NMR Analyst - ARD (Hyderabad)
🏢 Apitoria Pharma
📍 Hyderabad