岗位职责: 85 担任偶联技术子领域的SME,深入研究偶联技术在新型制剂产品开发中的应用,例如LNP偶联产品和重组蛋白偶联产品; Act as SME for conjugation technology and explore its applications in novel drug product development, such as LNP-based conjugates and recombinant protein conjugates. 85 承担项目FL职责,负责偶联制剂产品相关项目的推进,与内部团队和外部客户沟通,解决技术问题; Work as project function lead (FL) on conjugation-related projects, communicate with internal teams and external clients, and solve technical issues. 85 根据项目需求,设计偶联产品研发的实验方案,包括偶联反应条件筛选、参数优化、偶联效率提升及相关纯化工艺策略。 Design experimental plans for conjugated product R&D based on project requirements, including screening conjugation reaction conditions, optimizing parameters, enhancing conjugation efficiency, and developing related purification process strategies. 85 完成偶联及纯化相关实验和技术转移任务,包括工艺开发、工艺转移及稳定性研究等; Perform conjugation and purification-related experiments and tech transfer tasks, including process development, process transfer and stability studies. 85 参与偶联制剂产品开发相关的处方工艺实验和分析检测,对实验结果进行详细分析和总结; Participate in formulation process development studies and analytical testing experiments related to conjugated product development, conduct detailed analysis and summarization of experimental results. 85 独立地对实验和项目中出现的问题进行分析和解决,掌握文献调研能力,协助解决问题和优化工艺; Independently investigation and coordinating trouble-shooting on project; 85 结合团队现有工艺开发技术,探索新型偶联方法及工艺优化方向,包括酶法催化偶联和低毒化学偶联; Integrate existing process development technologies to explore novel conjugation methods and process optimization strategies, including enzymatic catalysis-based conjugation and low-toxicity chemical conjugation techniques. 85 持续优化新型制剂偶联和纯化技术能力,并推进相关平台建设,包括技术能力总结和参与制作推广材料; Continuously optimize capabilities for novel drug conjugation and purification technologies, and drive the development of related platforms, including summarizing technical capabilities and participating in the creation of marketing promotional materials. 85 按照公司的实验记录以及档案管理条例要求,认真按时整理实验记录和数据并提交归档,保障数据完整性,并撰写研究报告和相关申报资料; Ensure data integrity by completing experimental records, drafting technical reports, and preparing regulatory documentation. 85 遵守公司合规要求,确保研发工作的规范性; Adhere to company compliance requirements to ensure the integrity of R&D activities. 85 协助日常实验室管理,如仪器设备维护、耗材管理及SOP撰写等,担任偶联工艺相关设备的SME; Assist with daily laboratory management, including instrument maintenance, material management, and SOP writing, and serve as the SME for conjugation process-related equipment 85 积极参与团队协作,推动技术交流和知识共享。 Actively engage in teamwork and contribute to technical exchanges and knowledge sharing.
任职资格 Qualifications
1.化学、生物学、药学或相关专业硕士及以上学历;具有蛋白药物化学或生化偶联技术研发经验优先; Master’s degree or above in Chemistry, Biology, Pharmacy, or related fields; experience in drug conjugation technology development is preferred. 2.熟悉偶联反应机制及相关纯化技术,有药物制剂开发经验者优先; Familiarity with conjugation reaction mechanisms and related purification techniques; experience in drug formulation development is a plus. 3.具有较强的实验操作能力、问题分析能力及团队协作能力; Strong laboratory skills, analytical problem-solving ability, and teamwork skills. 4.英语读写能力优秀,能够撰写技术文件及与客户沟通。 Proficiency in English reading and writing; capable of drafting technical documents and communicating with clients.