Laboratory Executive

4 weeks ago


Pune, Maharashtra, India Enzene Biosciences Ltd Full time
  • To lead and perform method validation/verification activities (DS, DP, and in-process samples) and data review.
  • Conduct stability, qualification of IRS and biosimilarity activities, and data review.
  • Prepare and review documents like Specifications, STPs, TDS, SOPs, COAs, MVPs, MVRs, MTRs, etc.
  • Coordinate with vendors for external calibration and with MVL personnel for in-house calibration and verification of laboratory instruments and equipment.
  • Manage MVL labware's & materials (Chemicals, standards, kits, and consumables) indent and control of stock.
  • Maintain and manage laboratory equipment and instruments and usage logbooks.
  • Qualify analysts and train MVL employees.
  • Initiate, investigate, and track QMS activities.
  • Ensure MVL lab compliance in accordance with cGMP.
  • Adhere to safety rules at the workplace.
  • Perform other tasks assigned by the reporting manager.

Requirements

5-8 years of relevant hands-on experience and proficiency in tasks such as CEX-HPLC, SE-HPLC, ELISA, HCD by RT-PCR, HCP, Peptide Mapping, Glycan analysis, and Capillary Electrophoresis analysis.

Qualifications

Master's degree in Biotech or relevant subjects.


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