CMC Manager – Drug Product Expert

1. 01

   Oversee and technically govern external CDMO/partner drug product activities, including scope definition, technical due diligence, development/manufacturing readiness assessments, review/approval of protocols and reports, batch record/release package technical review (as applicable), deviation/investigation support, change control impact assessment, and ensuring on-time delivery with agreed quality standards. 监督并在技术上管理外部CDMO/合作伙伴的制剂活动，包括定义范围、技术尽职调查、开发/制造准备评估、方案和报告的审核/批准、批记录/放行包的技术审核（如适用）、偏差/调查支持、变更控制影响评估，确保按时交付且符合商定的质量标准。

2. 02

   Serve as the primary drug product technical owner for assigned programs, ensuring robust fill/finish process development, transfer, and lifecycle management from early development through commercial stage. 作为指定项目的主要制剂技术负责人，确保从早期开发到商业阶段的稳健制剂灌装工艺开发、转移和生命周期管理。

3. 03

   Act as a key technical interface between drug product process development, MST, manufacturing, quality, regulatory CMC, and external partners/CDMOs as needed. 作为制剂工艺开发、MST、生产、质量、CMC法规及外部合作伙伴/CDMO之间的关键技术对接。

4. 04

   Establish and drive a cross-department, cross-site unified technical strategy for a defined drug product technology topic (platform/process/standard), including governance, technical rationale, implementation roadmap, and change management. 为一个明确的制剂技术主题（平台/工艺/标准）建立并推动跨部门、跨工厂的统一技术策略，包括治理、技术依据、实施路线图和变更管理。

5. 05

   Establish and maintain an external drug product subject-matter expert (SME) advisor network to support fact-based consultation on controversial or disputed technical topics, enabling rapid risk assessment, option generation, and alignment on scientifically justified decisions. 建立和维护外部制剂主题专家顾问网络，以支持基于事实的咨询，处理有争议或存在分歧的技术主题，实现快速风险评估、方案生成和基于科学合理性的决策一致。

6. 06

   Support global post-approval lifecycle management: continuous improvement, change impact assessment, comparability support, and sustained process verification inputs. 支持全球批准后的生命周期管理：持续改进、变更影响评估、可比性支持和持续的工艺验证输入。

7. 07

   Potential CMC Lead responsibility (based on capability and organization need): coordinate end-to-end CMC execution for assigned programs, integrating drug product/downstream/analytical/drug product/supply and driving overall CMC strategy and decision making. 可能承担CMC项目负责人的职责（基于能力和组织需求）：协调指定项目的端到端CMC执行，整合制剂/下游/分析/制剂/供应，并推动整体CMC策略和决策制定。

8. 08

   Complete any other assignments as determined by supervisor. 完成主管确定的任何其他任务。 Education/ Professional

学历/专业资格 MS, or PhD in Biology, Biologics Engineering, Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering, or related scientific discipline 硕士或以上学历，生物药，生物工程，药物化学，有机化学，药剂学，药物科学，化学工程或相关学科 Technical/Skills Required 技术/技能需求 • Deep technical expertise in drug product processes. 在制剂工艺方面具有深入的技术专长。

• Strong understanding and hands-on experience in sterile fill/finish process, including engineering principles. 对无菌灌装工艺有深刻理解和实际操作经验，包括工程原理。

• Solid experience with process development and characterization, identification of CQAs/CPPs, and establishment of process control strategy. 在工艺开发和表征、CQAs/CPPs的识别以及工艺控制策略的建立方面具有扎实的经验。

• Proven capability in tech transfer to internal manufacturing and/or CDMO sites: transfer packages, readiness, on-site support, issue triage, and sustained process performance monitoring. 具备向内部制造和/或CDMO地点进行技术转移的能力：转移方案、准备工作、现场支持、问题分级处理和持续的工艺性能监控。

• Strong knowledge of cGMP expectations for drug product operations: deviation/OOS investigation support, CAPA, change control, contamination control mindset, and data integrity. 对制剂操作的cGMP要求有深厚的知识：偏差/超标调查支持、CAPA、变更控制、污染控制意识和数据完整性。

• Late-stage / commercialization experience preferred, including PC & PPQ readiness, process validation strategy inputs, comparability assessments, and post-approval changes. 具有后期阶段/商业化经验者优先，包括PC和PPQ准备、工艺验证策略输入、可比性评估和批准后的变更。

• Demonstrated ability to lead a technical topic/center-of-excellence initiative (e.g., wholistic particle control strategy) across functions and manufacturing sites to develop one globally aligned technical strategy. 展现出跨职能和跨工厂领导技术主题/卓越中心计划（例如整体颗粒控制策略）的能力，以制定全球统一的技术策略。

• Excellent interpersonal communication skills; able to mediate, influence, and drive decisions in complex cross-functional settings. 具备优秀的人际沟通技巧；能够在复杂的跨职能环境中协调、影响和推动决策。

• Structured problem solving, risk management, and milestone tracking. 具备结构化的问题解决、风险管理和里程碑跟踪能力。

• Demonstrated adaptability to changing work environments and ability to manage dynamic demands effectively. 展现出适应不断变化的工作环境的能力并能有效管理动态需求。

• High ethics, integrity, and alignment with organizational values. 拥有高尚的职业道德、正直和与组织价值观一致的表现。 Working Experience 工作经验 • Relevant experience in pharmaceutical or biotechnology 在制药或生物技术领域的相关经验 • MS: 5+ years 硕士5年以上工作经验 • PhD: 3+ years 博士3年以上工作经验 Language, Computer Literacy, Office Software, etc. 语言能力，电脑知识，办公软件等 • Fluency in Chinese and business English languages. 流利的中文和商务英语 • Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Project. 熟练使用Office办公软件，包括Word、Excel、PowerPoint和Project。 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.