Senior Manager Position Vacant @ Syngene | Apply Online

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Incorporated in 1993. Syngene is an internationally reputed custom research and manufacturing organization, which supports R&D programs from lead generation to clinical supplies. Our multi-disciplinary skills in integrated drug discovery and development include capabilities in medicinal chemistry, biology, in vivo pharmacology, toxicology, custom synthesis, process R&D, cGMP manufacturing, formulation and analytical development along with Clinical development services.

Our highly experienced scientific and project management teams ensure:

  • Timely execution of projects
  • Cost effectiveness and quality of the projects
  • Confidentiality and protection of intellectual property

Job Title  Senior Manager

Req ID : 2722

Job Description:

  • Guide the team for the preparation of URS/DQ/IQ/OQ/PQ documents & to ensure the adequacy and quality of documentation in line with emerging quality requirements
  • To look after method transfer activities related to Extractables & Leachables (E&L)& trace analysis
  • Hands on experience on the analysis and characterization of impurities at tracelevels
  • Review of SOPs, IOPs, protocols and reports related to the work stream
  • Hands on experience on deviation, change control and incident and OOS
  • Hands on experience in analyzing the E&L as per the compendial procedures (USP, EP…)
  • Hands on experience in execution of elemental impurities, trace metals, organic impurities and Polymer traces
  • Strong expertise in NMR , Mass spectrometry based characterization and quantization related to characterization of small organic molecules (API, Intermediates and Impurities) by LC-MS/ MS, GC-MS, NMR and other Spectrometric techniques.
  • Expert in chromatographic method development (using HPLC, UPLC, GC, IC, LC-MS/MS, GC-MS, ICP-OES) and Trace analysis (sub ppm) method development of E&L impurities and organic Volatile Impurities by LC-MS, LC-MS/MS, GC-MS, and GC-HS-MS.
  • Working experience in cGMP/GLP environment and USFDA audits
  • Desirable to have knowledge in appilication software such as ACD LABS – LC Stimulator, MS Fragmentor, NMR Predictor/Processor, Structure Elucidator, pKa Extender, ChemSketch and ISIS Chem Draw…………………
  • Working experience in cGMP/GLP environment and USFDA audits and thorough knowledge in ICH guidelines

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