Srishailam

Manufacturing Specialist @Hetero Biopharma

Shift In-Charge for downstream purification of monoclonal antibodies including Rituximab, Bevacizumab, Pembrolizumab, and Adalimumab. Experienced in operating advanced chromatography systems and filtration techniques such as depth filtration, microfiltration, Nano filtration, and tangential flow filtration (TFF).· Operate and maintain chromatography columns ranging from BPG and chromflow and Quick scale 300 mm to 600 mm Unicorn Software, including column packing, unpacking, and performance evaluation for process consistency.· Perform filter integrity testing on filters and cassettes, and operate single-use bag systems to minimize cross-contamination.· Execute bulk product formulation, ensuring accurate composition, compliance with batch protocols, and readiness for downstream processing.· Conduct pH, conductivity, and turbidity calibration and monitoring to maintain process quality and operational readiness in compliance with regulatory standards.· Ensure strict adherence to GMP compliance and Good Documentation Practices (GDP) across all operations.· Coordinate with cross-functional teams for buffer preparation, washing area management, chemical readiness, and batch material readiness to support smooth batch execution.· Supervise batch operations, monitor critical process parameters, and ensure timely execution according to production plans.· Provide team leadership, mentoring operators and junior staff to maintain high-quality standards and improve process efficiency.· Support continuous improvement initiatives to enhance purification yields, reduce deviations, and maintain cost-effective operations.