AST Physiochemical Manager

Lead analytical method transfer for physiochemical assays including strategy setting and execution; understand the project progress and timeline and complete the transfer and validation of analytical methods according to the project

. 带领实验室开展理化方法转移工作，包括策略制定和执行实验；了解项目进展和时间，根据项目要求完成分析方法转移和验证； Lead critical reagent and reference standard management, coordinate cross-departments to support reagent and RS global supply; 管理关键试剂和标准品，并跨部门协调支持试剂和标准品的全球供应； Responsible for product specification setting, shelf life setting and stability management; 负责产品质量标准设定、有效期设定和稳定性管理； Lead phase appropriate QC procedure optimization to fit business needs based on multiple region regulations including China/US/EU, establish and update related laboratory management procedures to keep abreast of laws and regulations; 根据中美欧多国法规要求和公司业务需求，优化阶段性QC管理规程，制定和升版实验室管理文件，确保符合法规要求 Lead product quality related change control, deviation/OOX investigation, CAPA, trend analysis, quality review and risk assessment; 主导产品质量相关的变更控制、偏差/OOX调查、CAPA、趋势分析、质量回顾和风险评估； Responsible for quality control related filing dossier writing; 负责质量控制方面的申报资料撰写工作； Build up team talent ladder and performance management system, inspire team to achieve goal and improve team members’ working capability; 建立团队人才梯队和绩效管理体系，激励团队目标的达成，推动团队成员能力提升； Any other assignment as is determined by supervisor. 完成上级安排的其他工作。 Master or above degree in Pharmaceutical, Chemical, Biological or related field. 药学、化学、生物学或相关学科硕士或以上学位。 Understand the GMP requirements of the Chinese Pharmacopoeia and other pharmacopoeias. 了解中国药典及其他药典GMP相关要求。 Familiar with drug inspection knowledge, laboratory safety knowledge, familiar with the use of physicochemical and biochemical related testing and analytical instruments. 熟悉药品检验知识、实验室安全知识，熟悉理化和生化相关检测及分析仪器使用。 Familiar with cell analysis methods development, validation and transfer. 熟悉分析相关方法开发、验证及方法转移。 Have good communication and coordination skills. 具有良好的沟通协调能力。 3 years or above working experience in biopharmaceutical analysis or management in pharmaceutical industry. 医药行业3年以上生物制药分析或管理经验。 Good command of English, familiar with computer operation, familiar with the use of office software. 英语水平良好，熟悉电脑操作，熟悉办公软件的使用。 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.