Senior Scientist, Biologics Analytical
beigene · 苏州市, 江苏, 中国
About The Role
Job Responsibility: 工作职责: Job responsibility may include the followings: 工作职责可能包括以下内容: Develop or support development of analytical methods for biological molecules (including monoclonal antibodies, multi-specific antibody, ADC, et.) to enable progression of biopharmaceutical development from preclinical to clinical stages. 开发或支持生物分子(包括单克隆抗体、多特异性抗体、ADC等)分析方法的开发,以推进生物制药从临床前阶段到临床阶段的开发。 Perform various analytical sample testing to support development of biological molecules as needed using a variety of Chem-Phys assays. For Chem-Phys assays may include analysis method with HPLC, UPLC, LC-MS, CE, ICIEF, Capliper. 根据需要, 使用各种化学-物理分析方法进行各种分析样品测试,以支持生物分子的开发。理化分析包括HPLC, UPLC, LC-MS, CE, ICIEF, Calipper等分析方法。 Write SOP, experimental methods and reports; Support sample preparation, reagent management, stability sample management. 撰写SOP、实验方法及报告;支持样品制备,试剂管理,稳定性样品管理 Participate/lead various studies to support CMC development of biological molecules, such as: CQA assessment, comparability study, biological molecular characterization beyond routine testing for product and process understanding and characterization. Support source document preparation including regulatory document authoring/revie 参与/领导各种研究,以支持生物分子的CMC开发,如: CQA评估,可比性研究,生物分子特性非常规测试,以理解和表征产品和工艺。支持源文件的准备,包括法规文件的编写/审阅,以支持各种类型的法规CMC文件的提交。 Job Requirement: 工作要求 : Master's degree or above in Pharmacy, Chemistry, Analytical Chemistry, or Biochemistry; or analytical related excellent professional expertise could be considered. 药学,化学,分析化学或生物化学专业硕士或以上学历;或者在分析专业领域表现出卓越能力的申请者也可获得优先考虑。 At least 3 years of practical experience in Bio-pharmaceutical industry for MS degree or above. 硕士或以上学历,医药行业3年以上生物制药经验。 At least 5 years of practical experience in Bio-pharmaceutical industry for BS degree. 学士学历,医药行业5年以上生物制药经验。 Be familiar with drug analytical testing, laboratory safety knowledge, analysis. 熟悉药品检验知识、实验室安全知识、检验和仪器分析知识。 Be familiar with analytical methods such as SEC,IEC,CE_NR&R, etc. 熟悉分析检测方法,如尺寸排阻色谱,离子交换色谱,还原&非还原凝胶毛细管电泳等。 Be able to experimental design, experiment execution, collect and summarize data, and resolve problems in experiments under supervision and guidance. 可以在监督指导下进行实验设计、执行实验、收集汇总数据,可以解决实验中的问题。 Effective verbal and written communication skills. 良好的口头和书面沟通技巧。 Other analytical related excellent professional expertise with more than 8 years of practical experience in Bio-pharmaceutical industry 具备卓越的分析相关专业技能,并在生物制药行业有超过8 年的经验。 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.
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