Job Responsibilities/岗位职责:
1. Responsible for process characterization, process validation, and risk assessment of related projects to ensure the robustness and reliability of conjugation processes.
负责相关项目的工艺表征、工艺验证和风险评估，确保偶联工艺的稳健性和可靠性；
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.
负责临床前阶段项目的ADC样品的制备（毫克到克级别）和偶联工艺开发工作，包括定点偶联和非定点偶联工艺的开发、优化及纯化工艺的开发,并撰写偶联工艺开发研究方案、研究报告及相关申报资料;
3. Execute technical transfer and process scale-up activities as required, and support pilot-scale production for toxicology batches.
按要求完成技术转移与工艺放大的工作，辅助毒理批中试生产；
4. Participate in laboratory document management, training, self-inspection, and rectification, and cooperate with QA inspections to ensure compliance with quality management requirements.
参与实验室文件管理、培训及自查整改工作，配合研发QA的监督检查，确保实验室符合质量管理要求；
5. Manage laboratory equipment and instruments, including acceptance, validation, maintenance, and calibration, to ensure smooth laboratory operations.
负责实验室工艺开发相关设备仪器的验收、验证、维护及管理，参与实验室仪器操作SOP的起草、培训及修订工作；
6. Implement EHS (Environment, Health, and Safety) requirements, handle hazardous waste and liquid disposal, and maintain laboratory hygiene standards.
执行EHS（环境、健康与安全）要求，处理实验室危险废弃物及废液，确保实验室环境卫生符合标准。
Job Requirements/岗位要求:
1. Master’s degree or higher in pharmacy, chemistry, bioengineering, biopharmaceutics, or related fields.
硕士及以上学历，药学、化学、生物工程、生物制药等相关专业；
2. 3+ years of experience in ADC conjugation R&D, process development, or technology transfer, or experience in downstream biopharmaceutical process development.
3年以上ADC偶联研发、工艺开发或技术转移经验，或生物制药下游工艺开发经验；
3. Familiar with biopharmaceutical CMC processes, conjugation chemistry, and process development; proficiency in protein purification and chromatography system operation.
熟悉生物药CMC流程，掌握偶联化学及工艺开发知识，具备蛋白纯化和层析系统操作等技能；
4. Skilled in the operation of advanced bioprocessing equipment, including ultrafiltration/diafiltration (UF/DF), tangential floe filtration (TFF), and fast protein liquid chromatography system such as AKTA. Familiar with the analytical methods for assessing critical quality attributes (CQA) of ADC.
熟练使用超滤/渗滤系统(UF/DF)、切向流过滤（TFF）、快速蛋白纯化仪（FPLC，AKTA）等设备，了解ADC关键质量属性（CQA）的检测方法；
5. Strong English reading and writing skills for report preparation and literature review; excellent communication, teamwork, and problem-solving ability.
具备良好的英语读写能力，能够撰写英文报告及文献检索；具备较强的沟通能力、团队协作精神及解决问题的能力。