li>Serve as the Subject Matter Expert (SME) for biopharma specific downstream unit operations, including chromatography (affinity, ion exchange), ultrafiltration/diafiltration (UF/DF), and IVT related purification steps, ensure consistent application of engineering and scientific principles during tech transfer, validation, and commercial production.
Lead deviation discussions and drive investigations of deviations and failures, apply root cause analysis tools (e.g., 5 Whys, cause and effect) and engineering problem-solving methodologies; support implementation of corrective and preventive actions and change controls through systems including TrackWise and Electronic Document Management Systems (EDMS).