Enzene Biosciences is hiring an Executive – Validation Lab for its Pune facility. This is an excellent opportunity for candidates with hands-on analytical validation experience in biologics, biosimilars, and GMP-regulated laboratories. The role focuses on method validation, stability studies, laboratory compliance, and advanced analytical techniques such as HPLC, ELISA, RT-PCR, and capillary electrophoresis.
This position is ideal for professionals looking to build a long-term career in biopharmaceutical quality and validation laboratories.
Key Responsibilities – Executive Validation Lab
As an Executive in the Validation Lab, you will be responsible for:
- Performing method validation and method verification for drug substances (DS), drug products (DP), and in-process samples
- Conducting stability studies, IRS qualification, and biosimilarity assessments
- Preparing and reviewing controlled documents including:
- Specifications
- STPs, SOPs, TDS
- COA
- Method Validation Protocols (MVP) & Reports (MVR)
- Method Transfer Reports (MTR)
- Coordinating with vendors for external calibration and supporting in-house calibration activities
- Managing validation lab inventory, chemicals, standards, kits, and consumables
- Maintaining laboratory equipment, instruments, and usage logbooks
- Conducting analyst qualification and training for MVL team members
- Initiating and tracking QMS activities, deviations, and investigations
- Ensuring cGMP compliance and adherence to workplace safety regulations
- Supporting additional tasks assigned by the reporting manager
Required Experience & Technical Skills
Candidates should have 2–5 years of hands-on laboratory experience with strong exposure to the following techniques:
- CEX-HPLC & SE-HPLC
- ELISA
- Host Cell DNA (HCDNA) by RT-PCR
- Maurice
- SOLO VPE
- Host Cell Protein (HCP) analysis
- Peptide Mapping
- Glycan Analysis
- Capillary Electrophoresis
Experience in biologics or biosimilar analytical validation is highly preferred.
Educational Qualification
- M.Sc / M.Pharm / Master’s Degree in Biotechnology or related life science disciplines
Salary & Benefits
- Expected Salary: ₹4,00,000 – ₹6,00,000 per annum (CTC), depending on experience
- Permanent role with long-term career growth
- Exposure to global biosimilar and biologics validation projects
- Work in a cGMP-compliant, regulatory-driven environment
- Professional training and analyst qualification opportunities
Job Location
- Pune, Maharashtra, India
