About this task

职位：CMC项目管理总监
汇报对象：首席制造官（CMO）
工作地点：美国，需常驻美国西海岸，优先洛杉矶。
薪资：80-110k。

岗位职责：
1. 负责海外CMC项目的端到端项目管理，制定、维护并跟踪项目计划，覆盖物料准备、生产与分析检测、工艺验证、稳定性研究、注册文件准备及申报等关键里程碑。
2. 协调内部跨职能团队及外部合作伙伴，组织海外项目会议、周会和阶段评审，推动国内外CMC活动对齐，跟踪行动项，确保项目按时间、质量和预算目标交付。
3. 识别、评估并沟通项目风险，协同相关职能制定并执行风险缓解措施，及时向管理层升级关键问题、偏差或潜在延期。
4. 作为项目管理核心，协调研发、生产、工程、质量、注册事务和供应链等内部及外部资源，确保沟通透明、协作高效、目标一致。
5. 作为与国内外CDMO合作伙伴的主要项目管理接口，负责项目进度跟踪、会议协调、行动项跟进和关键问题升级。
6. 管理与海外合同生产商及其他外部合作伙伴的项目沟通和运营协调，促进跨全球团队、地区和时区的顺畅协作。
7. 负责项目交付物与相关文件管理，支持CMC开发、技术转移、注册申报和商业化推进。

任职要求：
1. 生物技术、生物工程、化学工程、生化工程、药学、生物制药科学或相关专业本科及以上学历。
2. 熟悉药物开发流程，深入理解CMC活动，包括工艺开发、技术转移、工艺验证、GMP生产和注册申报。
3. 具备5年以上外部合作伙伴项目管理经验，有跨文化、跨时区团队协作经验者优先。
4. 熟悉质粒DNA生产工艺者优先，包括质粒DNA发酵、碱裂解、层析纯化和无菌灌装操作。
5. 具备7年以上CMC注册申报文件撰写和审阅经验者优先。
6. 理解项目管理方法和工具，能够独立制定详细项目计划，并使用专业项目管理工具管理进度、资源和风险。
7. 具备优秀的中英文书面和口头沟通能力，能够在跨部门、不同组织层级及外部机构之间进行专业有效沟通。

Position: Director, CMC Project Management
Reports to: Chief Manufacturing Officer (CMO)
Location: United States; must be based on the U.S. West Coast, preferably in Los Angeles.
Salary: 80-110k.

Responsibilities:
1. Lead end-to-end management of overseas CMC projects by developing, maintaining, and tracking project plans covering key milestones such as material preparation, manufacturing and analytical testing, process validation, stability studies, regulatory document preparation, and submissions.
2. Coordinate internal cross-functional teams and external partners, organize overseas project meetings, weekly meetings, and stage-gate reviews, align domestic and international CMC activities, track action items, and ensure delivery against timeline, quality, and budget objectives.
3. Identify, assess, and communicate project risks; work with relevant functions to develop and implement mitigation plans; and escalate critical issues, deviations, or potential delays to management in a timely manner.
4. Serve as the project management hub coordinating internal and external resources across R&D, manufacturing, engineering, quality, regulatory affairs, and supply chain to ensure transparent communication, effective collaboration, and aligned objectives.
5. Act as the primary project management liaison with domestic and international CDMO partners, overseeing progress tracking, meeting coordination, action-item follow-up, and escalation of critical issues.
6. Manage project communications and operational coordination with overseas contract manufacturers and other external partners to support seamless collaboration across global teams, regions, and time zones.
7. Manage project deliverables and documentation to support CMC development, technology transfer, regulatory submissions, and commercialization.

Qualifications:
1. Bachelor's degree or above in Biotechnology, Bioengineering, Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Biopharmaceutical Sciences, or a related field.
2. Familiarity with the pharmaceutical development process and a solid understanding of CMC activities, including process development, technology transfer, process validation, GMP manufacturing, and regulatory submissions.
3. 5+ years of experience managing projects involving external partners; experience working with cross-cultural and cross-time-zone teams is preferred.
4. Knowledge of plasmid DNA manufacturing processes is preferred, particularly plasmid DNA fermentation, alkaline lysis, chromatographic purification, and aseptic filling operations.
5. 7+ years of experience preparing and reviewing CMC regulatory submission documents is preferred.
6. Understanding of project management methodologies and tools, with the ability to independently develop detailed project plans and manage schedules, resources, and risks using professional project management tools.
7. Excellent written and verbal communication skills in both Chinese and English, with the ability to communicate effectively and professionally across departments, organizational levels, and external organizations.