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Job Responsibilities/崗位職責:
1.Responsible for process characterization, process validation, and risk assessment of related projects to ensure the robustness and reliability of conjugation processes.
負責相關(guān)項目的工藝表征、工藝驗證和風險評估，確保偶聯(lián)工藝的穩(wěn)健性和可靠性；
2.Responsible for the preparation of ADC samples (from milligram to gram scale) and development of conjugation process for preclinical-stage projects, including both site-specific and non-site-specific conjugation strategies, as well as the development, optimization, and purification process development， and draft conjugation process development research protocols, study reports and related regulatory submission documents.
負責臨床前階段項目的ADC樣品的制備（毫克到克級別）和偶聯(lián)工藝開發(fā)工作，包括定點偶聯(lián)和非定點偶聯(lián)工藝的開發(fā)、優(yōu)化及純化工藝的開發(fā),并撰寫偶聯(lián)工藝開發(fā)研究方案、研究報告及相關(guān)申報資料;
3.Execute technical transfer and process scale-up activities as required, and support pilot-scale production for toxicology batches.
按要求完成技術(shù)轉(zhuǎn)移與工藝放大的工作，輔助毒理批中試生產(chǎn)；
4.Participate in laboratory document management, training, self-inspection, and rectification, and cooperate with QA inspections to ensure compliance with quality management requirements.
參與實驗室文件管理、培訓及自查整改工作，配合研發(fā)QA的監(jiān)督檢查，確保實驗室符合質(zhì)量管理要求；
5.Manage laboratory equipment and instruments, including acceptance, validation, maintenance, and calibration, to ensure smooth laboratory operations.
負責實驗室工藝開發(fā)相關(guān)設備儀器的驗收、驗證、維護及管理，參與實驗室儀器操作SOP的起草、培訓及修訂工作；
6.Implement EHS (Environment, Health, and Safety) requirements, handle hazardous waste and liquid disposal, and maintain laboratory hygiene standards.
執(zhí)行EHS（環(huán)境、健康與安全）要求，處理實驗室危險廢棄物及廢液，確保實驗室環(huán)境衛(wèi)生符合標準。