About the role
Roles and ResponsibilitiesPerform method validation/verification activities for drug substances (DS), drug products (DP), and in-process samples.Conduct stability studies, qualification of IRS, and biosimilarity activities.Prepare documents such as Specifications, Standard Test Procedures (STPs), Technical Data Sheets (TDS), Standard Operating Procedures (SOPs), Certificates of Analysis (COA), Method Validation Protocols (MVP), Method Validation Reports (MVR), and Method Transfer Reports (MTR).Coordinate with vendors for external calibration and collaborate with MVL personnel for in-house calibration and verification of laboratory instruments and equipment.Manage MVL labware and materials, including chemicals, standards, kits, and consumables, along with inventory control and stock management.Maintain and manage laboratory equipment, instruments, and usage logbooks.Conduct analyst qualifications and provide training to MVL employees.Initiate, investigate, and track Quality Management System (QMS) activities.Ensure MVL lab compliance with current Good Manufacturing Practices (cGMP).Strictly adhere to workplace safety rules and regulations.Perform any other tasks assigned by the reporting manager.
Experience2 -5 years of relevant hands-on experience and proficiency in tasks such as CEX-HPLC, SE-HPLC, ELISA, HCDNA by RT-PCR, Maurice, SOLO VPE, HCP, Peptide Mapping, Glycan Analysis, and Capillary Electrophoresis analysis.
QualificationM.Sc., M.Pharm, or a Masters degree in Biotechnology or relevant subjects.