Scientist I/II, Biologics Analytical (cell-based potency/Biochemical analysis)

Responsibilities： Responsible for routine sample testing (residual HCP, DNA, protein A, binding ELISA, cell-based potency, et, al.) to meet the analytical needs of process development and manufacturing; 负责日常样品检测项目，如残留HCP、DNA、protein A、结合活性、细胞活性等，以满足工艺开发和生产的分析需要。 Participation in FAT、SAT、installation, and testing of the analytical lab equipment 参与蛋白分析实验室设备的FAT、SAT、安装和测试。 Draft and update of the SOPs of biochemical testing methods. 负责生化分析检测方法标准操作规程的起草和更新。 Draft the related study protocols, follow up the implementation of study protocols, and draft reports. 撰写并跟进研究方案，撰写研究报告。 Responsible for the development, optimization, qualification and transfer of biochemical analytical methods. 负责生化分析方法的开发、优化、确认和转移。 Responsible for sample analysis to support PD & MFG. 负责样品检测，以满足研发和生产的分析需要。 Participate in technology transfer, responsible for the review of biochemical related documents, and cooperate well with related department for successful technology transfer. 参与项目的技术转移，负责生化分析文件的审阅，与相关部门密切合作做好技术转移。 Cooperate well with USP &DSP &QC for process development. 与上游、下游实验室及QC紧密配合，保证工艺开发的完整性 Responsible for maintenance of instruments and cleaning of Analytical Lab. 负责实验仪器的维护和实验室内相关区域的清洁。 Responsible for providing guidance and training about experiment design and study design to junior colleagues. 负责对下级同事提供实验设计和研究设计方面的指导和培训。 Responsible for the IQ, OQ and PQ of related analytical instruments. Responsible for the daily work of the laboratory. 负责相关分析仪器的安装确认、操作确认和性能确认，负责实验室其他日常工作。 To comply with the requirements of the EHS policies and regulations. 遵守EHS相关政策法规的要求。 Any other assignment as is determined by supervisor. 完成上级安排的其他工作。 Qualifications Required: Master's degree or above in Pharmacy, Bioengineering or Biochemistry, or Bachelor with excellent professional expertise 药学、生物工程或生物化学专业硕士或以上学历；或本科教育学历，专业能力表现卓越 Be familiar with drug analytical testing, laboratory safety knowledge, biochemical analysis and instrumental analysis. 熟悉药品检验知识、实验室安全知识、生化检验和仪器分析知识。 Be familiar with analytical methods such as residual HCP, DNA, protein A, binding ELISA and cell-based potency. Be familiar with antigen and receptors affinity testing and flow cytometry. 熟悉分析检测方法，如残留HCP、DNA、protein A、结合活性和细胞活性等。熟悉抗原及受体亲和力检测、流式细胞术等。 Be familiar with analytical method development, optimization, qualification and transfer. 熟悉分析方法的开发、优化、确认和转移。 Strong laboratory analysis skills, and trouble shooting ability.具有较强的实验室分析能力，良好处理问题的能力。 Effective verbal and written communication skills.良好的口头和书面沟通技巧。 At least 2 years of practical experience in Bio-pharmaceutical industry. 医药行业2年以上生物制药经验。 Good English at reading & writing, familiar with basic computer skills. 英语读写水平良好，会熟练使用电脑 Proactive and dedicated with a strong sense of responsibility and integrity; 积极敬业、主动进取、责任心强、正直向上； Competent in organization and coordination, team spirit, analytical skills and problem solving; 有较强的组织协调能力、良好的团队精神、较强的分析和解决问题的能力 Good communication skills; 具有良好的沟通表达能力。 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 BeOne Global Competencies When we exhibit our values of Patients First, 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 求职者隐私申明： 百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。 由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（百济神州官网 - 隐私政策 - 求职者隐私政策）。 如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. Due to the reasonable business need for human resource management as a result of BeOne’s global operation, your personal information may be transferred and/ or stored in a server/database located in a third country (e.g., the United States) other than your own country. For further details, please refer to BeOne Job Applicant Privacy Policy (BeOne official website - Privacy Policy - Job Applicant Privacy Policy). If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeOne Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.