- 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.
- Robust technical writing, communication, and documentation skills, with the ability to collaborate effectively as a team player.
📌 Senior Executive (Pune)
🏢 Enzene Biosciences
📍 Pune
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