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 settings.

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.

Robust technical writing, communication, and documentation skills, with the ability to collaborate effectively as a team player.

📌 Senior Executive Pune
🏢 Enzene Biosciences
📍 Pune