Senior CMC Manager

Senior CMC Manager 发布于 2026-07-20 MJ022640 MJ022640 | CMC TM CMC TM | 全职 全职 | 广东·广州市 上海市 广东·广州市 上海市 Serve as the primary liaison between CMC team and other business partners. CMC团队和其他业务伙伴之间的主要联络人。 Accountable for availability of clinical and commercial suppliesLead and facilitate project meetings, ensuring the issuance of comprehensive agendas, action items, and meeting minutes.Monitor and optimize integrated project plans, including critical milestones, timelines, and resource allocation.Drive the management of regulatory submissions and launch readiness for relevant products across departments.Take accountability for the timely development of high-quality regulatory filing content and robust manufacturing processes.Foster a culture of open communication, effective collaboration, and proactive risk management within the team.Drive project-related decisions to ensure successful goal achievement and milestone completion.Lead the development and implementation of post-launch product life-cycle management strategies.Manage CMC-related contracts by overseeing contract creation, approval, and execution processes. CMC相关合同。 People management is typically required.Complete any other assignment as determined by supervisor.Support CMC strategy development CMC策略开发。Education/ Professional Qualification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Exceptional interpersonal communication skills, with the ability to mediate and persuade effectively.Comprehensive understanding of CMC aspects and extensive experience in managing CDMOs for cGMP manufacturing. cGMP生产中CDMO的管理有全面的了解和丰富的经验。 In-depth knowledge of FDA, EMEA, or China regulations relevant to cGMP manufacturing and regulatory filings. FDA, EMEA或中国与cGMP生产和监管文件相关的法规。 Strong leadership and project management skills, with a focus on driving results and fostering a positive team spirit.Demonstrated adaptability to changing work environments and ability to manage competing demands effectively.Commitment to ethics, integrity, and organizational values.People management experience is preferred.Working Experience工作经验Relevant experience in pharmaceutical or biotechnologyMS:10+ years 硕士10年以上工作经验PhD: 5+ years 博士5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 per

sonal information. Serve as the primary liaison between CMC team and other business partners. CMC团队和其他业务伙伴之间的主要联络人。 Accountable for availability of clinical and commercial supplies Lead and facilitate project meetings, ensuring the issuance of comprehensive agendas, action items, and meeting minutes. Monitor and optimize integrated project plans, including critical milestones, timelines, and resource allocation. Drive the management of regulatory submissions and launch readiness for relevant products across departments. Take accountability for the timely development of high-quality regulatory filing content and robust manufacturing processes. Foster a culture of open communication, effective collaboration, and proactive risk management within the team. Drive project-related decisions to ensure successful goal achievement and milestone completion. Lead the development and implementation of post-launch product life-cycle management strategies. Manage CMC-related contracts by overseeing contract creation, approval, and execution processes. CMC相关合同。 People management is typically required. Complete any other assignment as determined by supervisor. Support CMC strategy development CMC策略开发。 Education/ Professional Qualification 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 Exceptional interpersonal communication skills, with the ability to mediate and persuade effectively. Comprehensive understanding of CMC aspects and extensive experience in managing CDMOs for cGMP manufacturing. cGMP生产中CDMO的管理有全面的了解和丰富的经验。 In-depth knowledge of FDA, EMEA, or China regulations relevant to cGMP manufacturing and regulatory filings. FDA, EMEA或中国与cGMP生产和监管文件相关的法规。 Strong leadership and project management skills, with a focus on driving results and fostering a positive team spirit. Demonstrated adaptability to changing work environments and ability to manage competing demands effectively. Commitment to ethics, integrity, and organizational values. People management experience is preferred. Working Experience 工作经验 Relevant experience in pharmaceutical or biotechnology MS:10+ years 硕士10年以上工作经验 PhD: 5+ years 博士5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. 立即投递