Executive - Validation Lab

Enzene Biosciences Ltd.; Pune District; On-site; INR 600,000 - 900,000; Full time

Job summary

Enzene Biosciences Ltd. requires an experienced professional to lead method validation/verification for drug substances, products, and in-process samples. You will prepare key QA documents, coordinate calibrations, and manage lab inventory in a cGMP environment.

Additional responsibilities include training analysts, initiating QMS activities, and ensuring strict safety and compliance with regulatory standards.

Qualifications

• 2-5 years of hands-on experience in analytical methods for DS/DP and in-process samples.
• Experience with chromatographic and bioanalytical techniques listed above.
• Familiarity with documentation and SOPs for QA/QC in a biotech setting.

Responsibilities

• Perform method validation/verification for DS, DP, and in-process samples.
• Conduct stability studies, IRS qualification, and biosimilarity activities.
• Prepare Specifications, SOPs, COA, MVP, MVR, and MTR documents.
• Coordinate with vendors for external calibration and MVL calibration activities.
• Manage labware, chemicals, standards, kits, consumables, and inventory.
• Maintain instrument usage logs and schedule instrument upkeep.
• Train MVL staff and conduct analyst qualifications.
• Initiate and track QMS activities.
• Ensure cGMP compliance and strict safety adherence.
• Perform additional tasks as directed by the reporting manager.

Skills

CEX-HPLC

SE-HPLC

ELISA

HCDNA by RT-PCR

HCP

Peptide Mapping

Glycan Analysis

Capillary Electrophoresis

Education

M.Sc. or M.Pharm or MSc in Biotechnology

Tools

Maurice

SOLO VPE

Job description

Roles and Responsibilities

• Perform 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.

Experience

2 -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.

Qualification

M.Sc., M.Pharm, or a Masters degree in Biotechnology or relevant subjects.