Role Summary

We are seeking an accomplished Preparative HPLC Purification expert with more than 20 years of hands-on and leadership experience in the purification of complex pharmaceutical and biotechnology molecules. The role requires deep technical expertise in developing, optimizing, scaling up, and transferring purification processes from laboratory scale to plant scale, with solid exposure to process validation support and GMP manufacturing environments.

Key Responsibilities
- Lead preparative HPLC purification activities for peptides, ADCs, linkers, oligonucleotides, GalNAcs, small molecules, intermediates, and process-related impurities.
- Develop, optimize, and troubleshoot purification methods to improve purity, yield, recovery, throughput, robustness, and solvent efficiency.
- Scale up chromatographic purification processes from analytical and laboratory-scale systems to pilot, kilo-lab, and plant-scale operations.
- Drive technology transfer of purification processes from R&D; to manufacturing, ensuring technical readiness, documentation quality,



and process reproducibility.
- Support process validation batches at plant scale, including execution readiness, deviation investigation, data review, and technical troubleshooting.
- Provide scientific guidance for impurity isolation, characterization support, fraction strategy, column selection, loading optimization, gradient design, buffer selection, and purification workflow improvement.
- Collaborate with process chemistry, analytical development, quality assurance, manufacturing, engineering, regulatory, and project management teams to ensure successful project delivery.
- Ensure compliance with GMP, safety, data integrity, documentation, and applicable regulatory expectations.
- Establish best practices, standard operating procedures, training modules, and technical standards for preparative purification operations.
- Mentor, coach, and manage a team of approximately 1015 scientists, chemists, and techni

📌 Hiring For Preparative HPLC Purification Leader (Hyderabad)
🏢 Sai Life Sciences
📍 Hyderabad