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• Should have exposure in understanding the latest regulatory requirement of peptides both in US and EU market from analytical perspective and complex requirements like Nitrosoamines, Genotox Impurities, Elemental impurities etc.
• Reference standard characterization using different analytical techniques like LCMS, NMR, XRPD, DSC, TGA, Amino acid analysis, Ion Chromatography, Capillary Electrophoresis etc.
• Should be aware of characterization requirements for dossier filing and interpretation of results from high end machines GPC -MALLS, HRMS, LCMS,NMR etc.
• Maintaining & controlling quality standards to check all site activities; implementing QA / QC processes to monitor incoming & in-process activities on various products & records / documents during Analytical method Technology Transfer
• Should contribute towards DMF building and queries handling.
• Should have exposure to SOP writing and GLP requirements wrt regulatory guidelines.
• Broad exposure of 21 CFR software requirements and interpretation of Audit Trail and facing regulatory audits
• Should be proficient in drafting effective specifications for peptide APIs and KSMs as per the regulatory requirements of different regions.
• Should be willing to work independently on various development aspects like method development of Assay, Impurity Profiling, Aggregation studies etc.
• Must be aware of method validation and other GLP aspects of method validation as per EU, US and ICH guidelines.
• Proficient in using MS office WORD, EXCEL Power Point presentation skills will be an added advantage.
• Training of the team to align with the regulatory requirement of peptides wrt Validation, Characterizations, impurity profiles and train and maintain good documentation practices.
• Maintain the budget and cost control for drug substance related peptide projects

• Master in Science /Pharmacy/Doctorate in Related areas of chemistry branch like analytical / peptides

• The person should have 15 to 20 years of experience in the Peptides related area for analyzing drug substances and its complete DMF and dossier required