Senior/Director, Analytical Research & Development

A. Analytical Strategy and Control Strategy Leadership Act as a strategic partner to CMC, Process Chemistry, Formulation, Packaging, Clinical, Quality, Supply Chain, and Regulatory. Own the analytical control strategy for drug substance (DS) and drug product (DP), including impurity/degradant strategy, method selection, and control of critical quality attributes. Provide scientific leadership on phase-appropriate method development , justification of methods, and lifecycle management (method changes, comparability, continual improvement). Lead development of scientifically justified specifications (release and stability) for DS/DP, including statistical/clinical/refined approaches where appropriate. B. Stability Science and Shelf-life Strategy Direct stability programs (forced degradation, formal/accelerated/long-term stability, in-use stability as needed). Drive risk-based and predictive stability approaches to enable efficient shelf-life assignment and trend monitoring, ensuring robust change control and investigations. C. Analytical Method Development, Validation, and Transfers (Internal + External) Oversee development and

/validation of methods (e.g., HPLC/UPLC, LC-MS, GC, dissolution, KF, spectroscopy, residual solvents, particle/solid-state as needed). Ensure successful technical transfers to QC laboratories, CDMOs, and testing partners, including protocol strategy, acceptance criteria, troubleshooting, and lifecycle governance. Establish best practices for method robustness, system suitability, reference standards strategy, and critical reagent management. D. Regulatory and Health Authority Support Provide analytical leadership for global filings (IND/CTA, NDA/BLA/MAA) and responses to agency questions. Ensure alignment with relevant ICH guidance and industry expectations (analytical procedure development, validation/lifecycle, stability, specifications). Participate in inspections/audits and ensure inspection readiness for analytical areas. E. Organization Building, People Leadership, and Operational Excellence Lead and develop a high-performing AR&D sub-team (scientists, managers, and leaders); set expectations, coach, and plan succession. Establish a project-centered operating model: governance, KPIs, documentation standards, data integrity, and technology roadmaps. Manage outsourced strategy and vendor performance (CDMOs/CROs), including contracts, technical oversight, quality agreements, and cost/timeline accountability. Preferred Candidate Profile Education PhD in Analytical Chemistry or related discipline Experience Typically 12+ years (Director) or 15+ years (Senior Director) in small molecule analytical development Demonstrated leadership of analytic strategies across multiple assets and stages , including at least one late-stage/commercial program Proven experience with specification setting, stability science, method validation, and analytical control strategy for DS/DP Deep understanding of GMP expectations and successful collaboration with QC, QA, and external networks Technical Strengths Chromatography (HPLC/UPLC/GC), impurity/degradant profiling, dissolution, residual solvents, elemental impurities awareness, reference standards, nitrosamines. Familiarity with AQbD concepts, statistical tools for specification justification (e.g., simulation/Monte Carlo approaches), and risk-based decision frameworks. Strong track record in scientific publications Leadership Competencies Strategic thinking, prioritization, and decision-making across a portfolio. People leadership: hiring, coaching, performance management, and culture building. Clear communication for executive updates and regulatory interactions. Ability to operate effectively in a fast-paced, high-accountability environment. 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.