- Execute downstream manufacturing activities including buffer preparation, depth filtration, TFF, ultrafiltration/diafiltration and protein purification as per approved SOPs and batch records.
- Operate and monitor TFF systems, chromatography systems, pH meters, conductivity meters, spectrophotometers and filtration systems.
- Perform column packing, equilibration, sanitization and chromatography operations as per defined process parameters.
- Ensure proper execution of CIP/SIP, filter integrity testing, equipment cleaning and line clearance activities.
- Maintain accurate BMR/BPR, equipment logbooks, process records and GMP documentation with solid data-integrity practices.
- Monitor critical process parameters, perform in-process checks and report deviations, abnormalities and equipment/process issues promptly.
- Support process validation, technology transfer, scale-up, qualification and continuous process improvement activities.
- Ensure compliance with cGMP, SOPs, safety requirements and regulatory guidelines, while coordinating with QA, QC, Engineering and other cross-functional teams.