Roles & Responsibilities:
• Perform method validation and method verification for drug substance (DS), drug product (DP), and in-process samples.
• Conduct stability studies, IRS qualification, and biosimilarity assessments.
• Prepare and review controlled documents including specifications, STPs, SOPs, TDS, COAs, MVPs/MVRs, and MTRs.
• Coordinate with vendors for external calibration and support in-house calibration activities.
• Manage validation lab inventory, chemicals, standards, kits, and consumables.
• Maintain laboratory instruments, equipment, and usage logbooks.
• Conduct analyst qualification and training for validation lab team members.
• Initiate and track QMS activities, deviations, and investigations.
• Ensure cGMP compliance and adherence to laboratory safety requirements.
• Support additional tasks assigned by the reporting manager.
Qualification:
• M.Sc / M.Pharm / Master’s degree in Biotechnology or related life science disciplines.
Experience:
• 2–5 years of hands-on experience in analytical validation laboratories (biologics/biosimilars preferred).
Skills:
• Strong hands-on experience with CEX-HPLC, SE-HPLC, ELISA, RT-PCR (HCDNA), Maurice, SOLO VPE.
• Experience in HCP analysis, peptide mapping, glycan analysis, and capillary electrophoresis.
• Knowledge of stability studies, method validation, and biosimilarity testing.
• Sound understanding of cGMP, QMS, and laboratory compliance requirements.
• Strong documentation, coordination, and analytical skills.
About the Organization:
Enzene Biosciences is a biopharmaceutical company focused on the development and manufacturing of biologics and biosimilars for global markets. With advanced analytical and validation laboratories, Enzene offers professionals the opportunity to work with cutting-edge technologies while building expertise in GMP-regulated biopharmaceutical quality and validation operations.
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