工作职责: 1.负责制定项目开发策略及计划。 Responsible for project development strategies and plans. 2.负责制定纯化工艺开发阶段性目标,拆解工作任务并合理安排组员进行工作。 Responsible for formulating stage goals of purification process development, dismantling work tasks and reasonably arranging team members for work. 3.完成工作总结及汇报,完成工艺开发过程中各方案制定、撰写及执行,完成后报告撰写。 Complete the work summary and report, complete the formulation, writing and implementation of various plans in the process development process, and write the report after the completion. 4.能独立负责纯化工艺开发,并协助放大生产。 Independently responsible for purification process development and assist in scale-up production. 5.完成纯化相关项目管理和申报,确保符合注册法规与行业趋势。 Complete purification related project management and application to ensure compliance with registration regulations and industry trends. 6.负责纯化研发成本的核算。 Responsible for accounting of purification research and development costs. 7.负责管理、维护保养检验设备,确保检验设备可正常运行且在有效期内。负责新设备的安装、调试、校准、确认以及设备档案的建立工作。 Responsible for the management and maintenance of the inspection equipment to ensure that the inspection equipment can operate normally and within the validity period. Responsible for new equipment installation, debugging, calibration, validation and equipment file establishment. 8.完成领导分配的其他工作和职责。 Complete other tasks and responsibilities assigned by the leader. 9.负责保证所有的活动符合GMP/GLP的要求。 Be responsible for assuring that all the activities are in line with GMP/GLP requirement. 10. 负责保证所有的检测活动符合公司和总部的EHS方针和要求,确保检测的环境是安全的,人员的保护设备能按要求正确地使用。 Be responsible for assuring that all the testing activities are in line with the company and corporate EHS policies and requirements. Make sure that the production environment is safe and personal preventive equipment properly used as required. 任职资格: 1. 至少五年以上从事纯化工艺开发相关工作(至少包括亲和层析、阴阳离子层析、超滤、纳滤等)的实践经验。 At least five years of practical experience in purification process development related work (including at least affinity chromatography, anion and cation chromatography, ultrafiltration, nanofiltration, etc.). 2. 能够阅读相关的英文资料。 Be able to read related English materials.