职位描述
岗位职责:
一、活性方法开发管理Management of bioassay method development
1. 领导/协助分析团队开发理化及功能性试验,支持过程和产品放行开发检测
Lead/ assist analytical team to develop physiochemical and functional assays to support process and product development as well as product release.
2. 日常测试安排支持
Arrange and support routine testing
二、文件规程管理Document procedure management
1. 撰写或审核方法操作规程,方法开发报告等
Write or review SOP, method development report etc.
2. 指导和审核分析方法实验设计,方法确认方案和报告等
Guide and review analytical experimental design, testing methods and qualification protocols/reports.
三、 平台搭建 Platform construction
1 负责分析开发方法平台搭建Responsible for the analytical method of building the development platform
2 负责分析团队平台搭建Responsible for the analytical team platform construction
3 负责实验室平台搭建Responsible for the establishment of laboratory platform
四、 项目管理Project management
1 协助和支持各个项目如期进行Assist and support the implementation of various projects as scheduled
2 与其他同事紧密合作提供及时分析支持确保项目顺利进行,包括但不限于细胞株、工艺、制剂、质控、项目管理、商务等人员
Work closely with other colleagues to ensure timely analytical support for project, including but not limited to cell line, process, formulation, quality control, project management and business development
五、组织管理Organizational management
1 负责团队建设,以整体提升部门质量管理能力和水平
Responsible for team building to improve the quality management ability and level of the department as a whole
2 工作计划:分配下属工作任务,辅导下属制订工作计划,明确工作目标,指导、监控下属实现工作目标
Work plan: Assign tasks to subordinates, guide subordinates to make work plans, clarify work objectives, guide and monitor subordinates to achieve work objectives
3 部门会议:组织定期召开部门会议
Department meeting: Organize regular department meeting
4 预算管理:组织按照公司要求进行本部门的预算管理
Budget management: Organize the budget management of the department according to the requirements of the company
5 绩效考核:对下属进行绩效考核评估、绩效反馈沟通,辅导制订绩效改进计划
Performance assessment: Conduct performance assessment, performance feedback and communication for subordinates, and guide them to make performance improvement plans
6 团队建设:负责部门人员需求及人才发展规划、宣扬公司战略目标、企业文化,协助开展部门内部学习与文化建设,营造开拓创新、积极进取的工作氛围
Team building: Responsible for developing personal requirements and talent development plans of the department to publicize the company’s strategic goals and corporate culture, assisting in the internal learning and cultural construction of the department, and creating a pioneering, innovative and enterprising working atmosphere
7 辅导带教:指导、培养部门人员提升专业能力,组织制定部门培训计划并监督落实
Guidance and coaching: guide and cultivate department staff to improve their professional abilities, organize and formulate department training plans and supervise their implementation
任职要求:
1、 本科及以上学历要求;
2、 具有至少五年生物药各种抗体的分析方法开发的实践经验,包括但不限于单抗、双抗、融合蛋白、ADC等。其中至少一年的分析团队管理经验,接受过与产品相关的项目管理经验
Have at least five years of practical experience in the development of analytical methods for various antibodies of biological drugs, including but not limited to monoclonal antibody, bispecific antibody, fusion protein, ADC, etc. Besides, at least one year of experience in the management of analytical teams and project management experience related to the products
3、专业技能
(1). 具有直接的分析技术经验,如HCP,残留蛋白A,HCD,结合活性、细胞活性,SPR或BLI,Q-PCR, 酶标仪等
Hands on experience on analytical technologies such as HCP, residual Protein A, HCD, Binding ELISA, Cell-based assay, SPR/BLI, Q-PCR, Microplate Reader etc.
(2).有IND申报经验Experience in IND filing.
(3).熟练使用办公软件;具有良好的团队协作能力以及沟通协调能力
Proficient in office software; Good teamwork and communication skills
4、具有良好的英文读写能力优先;具有良好的语言表达能力
Good English reading and writing skills are preferred; Good language skills
5、具有较强的组织能力和管理能力
Have strong organizational ability and management ability
以担保或任何理由索取财物,扣押证照,均涉嫌违法,请提高警惕