工作职责: 1. 设计并开展大分子蛋白药物的理化性质研究,如抗体、双抗、融合蛋白、ADC等。 Design and conduct physicochemical property studies for large molecule protein drugs, such as antibodies, bispecific antibodies, fusion proteins, ADCs, etc.; 2. 进行蛋白药物分析方法开发、方法确认和验证,包括但不限于SEC, CE-SDS、电荷变异体、糖型、表达量、以及产品及工艺相关杂质检测等,产生高质量数据,并对数据进行分析,撰写报告。 Develop analytical methods, including but not limited to SEC, CE-SDS, charge variants, glycan, titer, , and product/process-related impurity analysis. Perform analytical method qualification and validation. Generate high-quality data, make conclusion and reports. 3. 支持细胞系开发、上下游工艺、制剂处方开发高通量样品分析,对数据结果进行分析和反馈;支持工艺放大和中试阶段检测工作,进行早期临床稳定性研究。 Support high-throughput sample analysis for cell line development, upstream/ downstream processes, and formulation development. Analyze and provide feedback on data results. Support analytical testing during process scale-up and pilot phases. Conduct early clinical stability studies. 4. 按要求完成实验记录、研究方案和报告等资料撰写,保证数据完整性。 Complete experimental records, study protocols, and reports in accordance with requirements, ensuring data integrity. 5. 负责相关仪器、设备的维护和保养。 Responsible for the maintenance and upkeep of relevant instruments and equipment.
任职资格: 1. 生物化学、分析化学、药物化学或相关学科的本科或硕士,2年及以上制药或生物技术公司工作经验。 Bachelor or Master’s degree in biochemistry, , analytical chemistry,pharmaceutical chemistry, or related background with 2+ years of biotech industrial experience. 2. 熟练掌握大分子分析技术,精通高效液相色谱及毛细管电泳技术,包括但不限于HPLC, UPLC, CE-SDS, iCIEF等。 Hands-on experiences in analytical development and/or quality control testing for biologics, with expertise in high-performance liquid chromatography and capillary electrophoresis techniques including but not limited to HPLC, UPLC, CE-SDS, iCIEF, etc. 3. 文献阅读和解决问题的能力,良好的沟通和团队合作能力,较强的责任心和执行能力。 Literature search to solve problem as needed ; good communication and teamwork skills;strong sense of responsibility; excellent execution ability.