Senior Executive

• Operation and handling of chromatography systems for downstream bioprocessing applications.
• Column packing, qualification, and performance evaluation.
• Performing basic chromatography-related calculations, including resin volume, flow rates, residence time, and buffer requirements.
• Operation and monitoring of Tangential Flow Filtration (TFF) systems for concentration and diafiltration processes.
• Preparation, review, and execution of chromatography process recipes and batch records.
• Troubleshooting and resolving issues related to downstream processing equipment and operations.
• Working knowledge of Quality Management Systems (QMS), including compliance, documentation, and deviation management.
• Understanding and application of ICH Q7 and cGMP guidelines in pharmaceutical and biopharmaceutical manufacturing environments.
• Knowledge of facility design and layout in accordance with cGMP requirements, with focus on personnel flow, environmental controls, and safety standards.
• Experience with Single-Use Technologies (SUT) and their implementation in bioprocessing operations.
• Strong technical writing, communication, and documentation skills, with the ability to collaborate effectively as a team player.

Skills Required
cGMP guidelines, chromatography systems