Lead biologics QC method transfer, method validation and continual method performance monitoring;
负责大分子QC分析方法转移，验证和持续方法监控；
02Lead biologics specification setting and updating;
负责大分子质量标准建立和升级；
Lead biologics release and stability comparability study;
负责大分子放行和稳定性可比性研究；
02Lead reference standard and critical reagent management;
02负责大分子参比品和其他关键试剂的管理；
Lead QC submission document preparation and review for IND and NDA;
负责IND和BLA中QC注册相关文件准备和审核；
Manage or participate the project management on the QC related new product technology transfers;
负责和参与QC实验室相关的新产品技术转移的项目管理工作；
Proactively interact and communicate with cross functional teams in and out of QC to accurately deliver the information and collect the feedback on the QC operation in time;
积极与QC内外的跨部门进行交流和沟通，及时为QC的运作传达准确的信息以及搜集相关的反馈；
Support and assist QC head on QC department management;
支持和协助QC负责人对QC部门进行管理；
02Complete other work items arranged by leaders.
完成上级领导安排的其他工作任务。
02
02Bachelor or above degree in Pharmaceutical engineering, bioengineering, analytical science related fields.
本科或以上学历，制药工程、生物工程、分析科学等相关专业Experienced and deep understanding in biologics analytical science and QC operation;
理解并有大分子分析科学和QC运行的经验;
Expertise in quality control principles, practices and standards for the biopharmaceutical industry;
具有生物制药行业质量控制，良好规范和相关标准的专业知识；
02Familiar with the ChP/USP/EP, cGMP/EU GMP and ICH Q guidance;
熟悉中国药典，美国药典，欧洲药典，cGMP/欧盟GMP及ICHQ的相关要求；
Good communication and coordination ability;
具有良好的沟通协调能力；3 years and more working experience in pharmaceutical analysis, large molecule experience preferred;
医药行业3年以上药物分析工作经验，有大分子经验者优先；
021 year and more project management experience, with operational excellence project experience preferred;
项目管理经验1年以上，有卓越运营项目经验者优先；Fluent with English and Chinese in both oral and written communication；
具有流利的英语和中文口语和书面沟通能力；
Familiar with Microsoft office software and common statistical software (e.g.Minitab, JMP).
熟悉微软办公软件和常见的统计软件（如Minitab，JMP）
02
百济神州全球胜任力
当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。
●团队协作
●提供并征求坦诚及可行的反馈
●自我认知
●兼容并蓄
●积极主动
●开拓精神
●持续学习
●拥抱变化
●结果导向
●分析性思维/数据分析
●卓越财务
●清晰沟通
BeiGene Global Competencies
When we exhibit our values of Patients ***, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
●Fosters Teamwork
●Provides and Solicits Honest and Actionable Feedback
●Self-Awareness
●Acts Inclusively
●Demonstrates Initiative
●Entrepreneurial Mindset
●Continuous Learning
●Embraces Change
●Results-Oriented
●Analytical Thinking/Data Analysis
●Financial Excellence
●Communicates with Clarity
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