Bioconjugation reactions and purification of antibody intermediates and conjugated drug substances. Perform downstream protein purification manufacturing operations for drug substances under the guidance of SOPs. This includes, but is not limited to, chromatography system operation, conjugation, low pH viral inactivation operation, nano filtration operation, ultrafiltration washing and filtration operation, and final bulk dispensing. Operate equipment and appliances following the guidance of SOPs and relevant documents. Prepare relevant documents, such as production batch records, SOPs, and validation reports. Communicate and resolve inconsistencies and/or anomalies in production operations. Monitor processes, including real-time review of process parameters, data, and trends. Ensure that the manufacturing operation of drug substances complies with quality and safety regulations. Complete other tasks assigned by superiors. Participate in shift production as required, ensuring compliance with SOP requirements.
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