- Desirable to have PhD / MSc (Analytical / Organic chemistry) with 20 to 27 years of experience in API research and development facility for API And intermediates.
- Exposure to close interactions with Regulatory Affairs, DQA, manufacturing locations and third parties absolutely essential.
- Good scientific understanding of Structural characterisation, Purification and isolation of impurities, solid state characterisation, Chromatographic (HPLC, GC, SFC and CE) methods development and validations.
- Strong Technical skills in HPLC, GC, IC, Wet chemical analysis, pXRD, DSC, ICP-MS, LCMSMS, GCMS, particle size analysis, DVS.
- Exposure to Methods validation and regulatory audits.
- Extensive experience in facing regulatory audits - USFDA, EDQM, WHO etc in a leadership role
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