Research Investigator, Upstream

Ÿ Project development, process development and characterization 项目研发、工艺开发与工艺表征 • Leading and participating in early IND projects: Responsible for the development, scale-up, and toxicology batch production of cell culture and harvest processes for novel antibodies (such as BsAbs, TsAbs, ADC, or other novel antibody molecules) or complex recombinant proteins. Ensure projects progress as planned and are delivered on time. Cell culture processes need to be developed in conjunction with platform processes suitable for 2L/3L bioreactor conditions and confirmed in 10L, 50L, or larger bioreactors. Harvest processes need to be evaluated and optimized in conjunction with platform processes, confirming scalable parameters for centrifugation, depth filtration, and sterile filtration. 主导和参与早期IND项目：负责新型抗体（如双抗、三抗、ADC或其他新型抗体分子）或复杂重组蛋白的细胞培养工艺及收获工艺开发、放大和毒理批生产，确保项目按计划推进及按时交付。细胞培养工艺需结合平台工艺开发适合的2L/3L反应器细胞培养条件，并在10L或50L或更大规模反应器中完成确认。收获工艺需结合平台工艺评估及优化，确认可放大的离心、深层过滤和除菌过滤参数等。 • Leading and participating in late-stage projects: Leading and participating in the establishment and confirmation of scaled-down models for cell culture and/or harvest processes, conducting process characterization studies, identifying CPP/KPP parameters during the process, and determining the design space for each parameter. 主导和参与晚期项目：主持和参与细胞培养和/或收获工艺缩小模型建立和确认，进行工艺表征研究，识别工艺过程中参数的CPP/KPP，并找出各参数的设计空间。 • Leading and participating in Tech. transfer: Leading and participating in the technology transfer of CRO/CDMO/MAH projects, closely collaborating with relevant personnel to complete project transfer in or out, confirm the process for transferred-in projects, and support and assist MST/DS or other receiving units in understanding the process flow, completing small-scale process transfer or larger-scale process scale-up. 主导和参与技术转移：主导和参与所负责CRO/CDMO/MAH项目的技术转移，与相关人员密切配合，完成项目的转入或转出，实现转入项目的工艺确认，支持并协助MST/DS或其他接受单位完成工艺流程的理解，完成小试工艺转移或更大规模工艺的放大。 • Overcoming key technical challenges: Solving key technical challenges in the upstream process development, scale-up, and transfer, such as process complexity, robustness, and scale-up inconsistencies, to successfully transition developed projects to commercial manufacture. 关键技术难题攻克：解决项目开发、放大及转移过程中的关键技术难题，如工艺复杂性、稳健性、放大不一致等各种问题，推动研发项目向商业化生产的成功转移。 Ÿ Cutting-Edge Technology Exploration and Innovation 前沿技术探索与创新 • Ai-driven cell culture prediction models: Introducing AI-driven cell culture prediction models, using machine learning to analyze the correlation between process parameters and cell growth and expression behavior, and building the intelligent process control platform. AI驱动的细胞培养预测模型：引入AI驱动的细胞培养预测模型，利用机器学习分析工艺参数与细胞生长、表达行为的关联性，搭建智能化工艺控制平台。 • Evaluating advanced upstream technologies: Assessing the feasibility of advanced upstream technologies (such as continuous flow culture, PAT automatic control culture) to drive process innovation, reduce production costs, or improve development and manufacture efficiency. 新型上游技术调研及应用：评估新型上游技术（如连续流培养，PAT自动控制培养）的可行性，推动工艺革新以降低生产成本或提高研发和生产效率。 Ÿ Cross-Department Collaboration and Support 跨部门协作与支持 • Difficult problems solving through cross-departmental collaboration: Leading and participating in collaborative problem-solving with downstream processes, analytical, and CMC teams to address process integration issues (such as HCCF stability and clarity, continuous flow production integration, etc.). 跨部门协作攻关：主持和参与和下游工艺、分析、CMC团队的协同攻关，解决工艺衔接问题（如HCCF稳定性及澄清度，连续流生产衔接等）。 • Technical transfer support: Providing technical transfer support for IND and BLA, developing process control strategies to ensure compliance with FDA/EMA/NMPA regulations. 技术转移支持：为IND及BLA提供技术转移支持，制定工艺控制策略，确保符合FDA/EMA/NMPA等法规要求。 Ÿ Project Management and Technical Guidance 项目管理与技术指导 • Technical risk assessment and decision-making: Participating as an SME in project decision-making, providing technical risk assessments and risk mitigation strategies (such as the impact of process changes on comparability). 技术风险评估与决策：作为SME参与项目决策，提供技术风险评估与风险缓解策略（如工艺变更对可比性的影响）等。 • Experimental design and optimization: Participating in or guiding team members to complete experimental design (such as DoE for optimizing quality attributes during process changes), using statistical tools (such as JMP) to optimize process parameters and develop proprietary technical solutions. 实验设计与优化：参与执行或指导小组成员完成负责实验设计（如工艺变更时优化质量属性的DoE等），通过统计工具（JMP等）优化工艺参数，形成专有的技术方案。 • Document drafting and review: Responsible for drafting or reviewing project risk assessment reports, process development reports, process characterization summary reports, and process descriptions. Reviewing experimental protocols, records, reports, and related documents from team members. 文件起草与审核：负责起草或审核所负责项目风险评估报告、工艺开发报告、工艺表征总结报告和工艺描述等文件。审核组内他人实验方案、记录、报告及相关文件。 Ÿ Industry Insights and Knowledge Sharing 行业洞察与知识分享 • Tracking and sharing technical trends: Keeping up with domestic and international technical trends, sharing insights within and outside the department, and planning for technical route upgrades or optimizations. 技术动态跟踪与分享：跟踪国内外技术动态，在部门内外进行分享和技术路线升级或优化规划。 • Academic contributions: Publishing papers or patents, representing the company at industry academic conferences to enhance the company's technical influence. • 学术贡献：发表论文或专利，代表公司参与行业学术会议，提升公司技术影响力。 Ÿ Other Departmental Work 其他部门工作 • Performing lab cleaning and daily maintenance as required, working under TD lab 6S management rules and company EHS management regulations. 按要求进行实验室的清洁和日常维护工作，在TD实验室6S管理规则和公司EHS管理规定下开展工作。 • Completing other tasks assigned by superiors. 完成上级安排的其他工作。 Bachelor or above degree in Biopharmaceuticals, Biology, Biochemistry, Biotechnology, Bioengineering, Biological Sciences, etc. 生物制药、生物学、生物化学、生物技术、生物工程、生物科学等相关专业本科及以上学历 Experience with project management, including the project from lab-scale process development to pilot bioreactors scale-up and validation of antibodies, recombinant protein and so on. Preferably experience in commercial bioreactor scale-up and validation or process develop experience in novel antibodies. 有项目管理经验，参与过抗体、重组蛋白等相关领域项目由小试工艺开发，到中试工艺放大（50L-200L 规模生物反应器）和验证，有商业化生产放大和验证经验者或新型抗体研发经验优先。 Rich experience in upstream cell culture and harvest process, be able to organize junior technical staff to successfully design and execute experiments. 丰富的上游细胞培养和收获工艺工作经验，能组织下级技术人员成功实验设计和执行实验。 Have skillful data statistical analysis ability and experiment design ability, can use relevant software for data statistical analysis and design experiment scientifically.具备熟练的数据统计分析能力和实验设计能力，能使用相关软件进行数据统计分析和科学的实验设计。 Understand the relation between upstream (cell culture and harvest), front side (cell construction, cell bank building and testing et,al.), back side (downstream purification) and server side(quality attributes analysis). 了解细胞培养、收获工艺等上游技术与前端细胞株构建、细胞库建立/检定，后端下游纯化及服务端质量属性分析之间的关系。 Scientific mindset can summarize and present the project progress or study results inside and outside the department to influence TD departments and project team to make scientific and correct decisions. 具有较强的科学思维能力，能在部门内外开展项目进展及研究结果的总结和汇报，影响TD部门或项目组做出科学、正确的决策。 Ability to accelerate the project progress combing the upstream platform advantage, find the defects of the existing technology platform, improve the platform technology, and solve the high-frequency routine problems in the process of cell culture with the help of experience and new technology. 管理项目过程中能充分发挥上游平台技术优势，加速项目推进，同时能发现现有技术平台缺陷，改进平台技术，并通过经验或借助新技术解决细胞培养过程中非常规、关联度广的问题。 Be familiar with the general and routine regulations, pharmacopoeia and guidelines in pharmaceutical. 熟知医药研发领域的通用及常规法规、药典和指南。 Working Experience 工作经验 BS 7~8 years, MS 5~6 years or PhD 1-3 years relevant experience in CHO cell culture process development for monoclonal antibodies, bispecific antibodies, and other therapeutic proteins. 本科7-8年、硕士5-6年或博士1-3年在抗体、双特异抗体或其它治疗性蛋白领域的CHO细胞培养相关工作经验。 Language, Computer Literacy, Office Software, etc. 语言能力，电脑知识，办公软件等 Ÿ CET-6 or advance qualification can read and write with English fluently. 英语六级以上，熟练的英语阅读和书写能力。 Ÿ Familiar with the Office software like the Word, Excel, PowerPoint. 熟练掌握Word, Excel，PowerPoint等Office办公软件。 Ÿ Be able to use statistical analysis software and experiment design software skillfully. 能够熟练使用统计分析软件和实验设计软件。 Others 其他 Ÿ Be able to learn, update and strengthen the technology related to upstream actively. 主动学习上游相关新技术，新方法，更新和扩充上游工艺知识。 Ÿ 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。 Ÿ 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。 Ÿ Good communication skills. 具有良好的沟通表达能力。 Ÿ Have competent coaching skills and good managerial skills. 具有较强的指导能力和良好的管理能力。 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. 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