作为ADC payload linker部分项目负责人,制定项目时间线和整体开发计划, 并确保项目按计划执行。As ADC payload linker project leader, design timeline and development plan, and ensure the project on track.
负责ADC项目payload linker部分在CDMO的工艺开发,优化和生产管理。Process development, optimization, and manufacturing management in CDMO of payload linker for ADC project.
独立或者带领团队在内部实验室开发payload linker的合成和生产工艺。Develop synthesis and manufacturing process for new drug substance in internal lab independently or as a team leader.
撰写、报告和解释实验结果。Write, report, and interpret experiments’ result.
总结和管理项目开发和生产过程中积累的知识,撰写技术报告。Summarize and manage the knowledge accumulated during project development and manufacturing.
熟悉ADC药物开发的流程和相应的注册法规需求。Familiar with the development process and related registrational requirements of ADC project.
良好的GMP和质量合规意识。Good awareness on GMP and quality compliance to ensure.
为ADC新药(payload linker 部分)注册申报提供技术支持。Provide technical support for regulatory filing of ADC new drug (payload linker part).
与其他业务部门(包括药化,毒理,分析,质量,注册等)顺利交流。Communicate with other line functions (including medchem, tox, analytical, quality, registration etc.).
其他要求
博士学历,机化学,药物化学等相关专业。Ph.D. degree, Major in organic chemistry, medicinal chemistry, etc.
熟练掌握化学实验操作,特别是高活性化合物 (OEB4-5). Proficient in operating chemical experiments, especially for handling high potency compounds (OEB4-5)
具备扎实有机合成理论基础。Strong academic knowledge in organic synthesis
英文听写熟练。 Proficient in oral and written English
熟练办公及实验软件操作。Skilled in office/lab software operation.