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:Â Â Senior Manager
Req ID :Â 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
