生物药研发项目经理| Project Manager, Biologics Development & Governance

岗位职责| Key Responsibilities

1. 项目规划与治理管理| Project Planning & Governance

• 负责生物药研发项目全生命周期项目管理工作，覆盖项目立项、规划、执行、监控、阶段门评审及项目结项。

Lead end-to-end project management activities across the biologics development lifecycle, including project initiation, planning, execution, monitoring, stage-gate reviews, and project closure.

• 协助项目负责人（Project Leader）制定项目章程、项目管理计划、主计划、关键里程碑、关键路径、工作分解结构、职责矩阵及关键交付物。

Support Project Leaders in developing Project Charters, Project Management Plans, integrated timelines, key milestones, critical paths, Work Breakdown Structures (WBS), RACI matrices, and key deliverables.

• 建立并维护项目范围、进度、预算和资源基线，确保项目目标和执行路径清晰可控。

Establish and maintain project scope, schedule, budget, and resource baselines to ensure project execution remains aligned with approved objectives.

• 建立项目治理机制、沟通机制及管理汇报体系，确保项目符合公司项目治理要求。

Establish governance processes, communication mechanisms, and reporting structures to ensure compliance with corporate project governance standards.

2. 项目执行与跨部门协同| Project Execution & Cross-functional Coordination

• 推动早期研究、CMC开发、IND/BLA申报支持、技术转移、工艺验证、生产放大及商业化准备等项目活动按计划推进。

Drive project execution across early research, CMC development, IND/BLA submission support, technology transfer, process validation, scale-up, and commercialization readiness activities.

• 协调研发、工艺开发、分析开发、制剂开发、质量、法规、临床、生产、供应链、采购及财务等跨职能团队协作。

Coordinate activities across Research, Process Development, Analytical Development, Formulation Development, Quality, Regulatory Affairs, Clinical Development, Manufacturing, Supply Chain, Procurement, and Finance functions.

• 跟踪关键里程碑、关键路径及核心交付物状态，及时识别项目偏差并推动解决方案落地。

Track critical milestones, critical path activities, and key deliverables; identify deviations and drive resolution plans to maintain project objectives.

• 管理外部合作伙伴（CRO、CDMO及供应商），确保项目高质量交付。

Manage external partners, including CROs, CDMOs, and suppliers, to ensure quality, timeline, and delivery expectations are achieved.

3. 风险、问题与变更管理| Risk, Issue & Change Management

• 建立并维护项目风险登记册、问题台账、行动项清单及决策记录。

Develop and maintain project Risk Registers, Issue Logs, Action Trackers, and Decision Logs.

• 组织风险识别、风险评估及风险缓解活动，推动风险预防和控制措施落地。

Facilitate risk identification, assessment, mitigation planning, and implementation of risk control measures.

• 推动跨部门问题分析与闭环管理，确保关键问题及时解决。

Drive cross-functional issue resolution and ensure timely issue closure.

• 组织项目范围、时间、预算及资源变更评估和审批流程，确保项目变更受控。

Lead project change control processes covering scope, timeline, budget, and resource changes.

• 对重大风险、重大偏差及关键决策事项及时预警，并推动升级管理。

Escalate major risks, project deviations, and critical decisions to governance bodies and leadership teams when necessary.

4. 项目预算与资源管理| Budget & Resource Management

• 协助项目预算编制、预算基线建立及资源需求规划。

Support budget planning, baseline establishment, and resource forecasting activities.

• 跟踪预算执行情况，开展预算偏差分析、Forecast/LE管理及预算风险预警。

Monitor budget performance, perform variance analysis, support forecasting/Latest Estimate (LE) processes, and identify financial risks.

• 协调财务、采购及供应链团队，确保项目预算和资源投入与项目计划保持一致。

Collaborate with Finance, Procurement, and Supply Chain teams to align project investments with approved plans.

5. 项目治理与管理层汇报| Governance & Executive Reporting

• 组织项目例会、专项协调会、风险评审会、预算回顾会及阶段门评审。

Organize project governance meetings, risk reviews, budget reviews, cross-functional workshops, and stage-gate reviews.

• 编制项目周报、月报、项目健康度报告（Dashboard）及管理层汇报材料。

Prepare weekly reports, monthly reports, project dashboards, and executive presentations.

• 支持项目治理委员会及管理层对项目关键节点、资源需求、重大风险和战略事项进行决策。

Support governance committees and leadership teams in decision-making related to project milestones, resource allocation, strategic priorities, and critical risks.

• 确保项目符合质量体系、法规要求及项目治理体系要求。

Ensure projects comply with quality systems, regulatory requirements, and internal governance standards.

6. 项目复盘与持续改进| Project Close-out & Continuous Improvement

• 组织项目结项、经验教训总结及知识管理活动。

Lead project closure activities, lessons learned reviews, and knowledge management initiatives.

• 推动项目管理流程、方法、工具和模板持续优化。

Continuously improve project management processes, methodologies, tools, and templates.

• 支持组织项目管理能力建设和项目治理成熟度提升。

Support organizational capability building and project governance maturity improvements.

任职要求| Qualifications

教育背景| Education

• 生物学、生物化学、分子生物学、免疫学、药学、生物工程、制药工程等相关专业硕士及以上学历，博士优先。

Master's degree or above in Biology, Biochemistry, Molecular Biology, Immunology, Pharmacy, Bioengineering, Pharmaceutical Engineering, or related disciplines. PhD preferred.

工作经验| Professional Experience

• 5年以上生物医药行业相关工作经验。

Minimum 5 years of experience in the biopharmaceutical industry.

• 其中3年以上生物药研发、CMC开发、技术转移、注册申报支持或项目管理经验。

At least 3 years of experience in biologics development, CMC development, technology transfer, regulatory submission support, or project management.

• 具有抗体、双抗、ADC、融合蛋白或重组蛋白开发经验者优先。

Experience with monoclonal antibodies, bispecific antibodies, ADCs, fusion proteins, or recombinant proteins is preferred.

• 具有IND/BLA申报、工艺放大、技术转移、GMP生产支持或商业化准备经验者优先。

IND/BLA submission support, process scale-up, technology transfer, GMP manufacturing support, or commercialization experience is highly desirable.

专业能力| Technical & Project Management Competencies

• 熟悉生物药研发全生命周期管理。

Strong understanding of the biologics development lifecycle.

• 熟悉项目规划、关键路径管理、里程碑管理、预算管理、风险管理、问题管理及变更管理。

Solid knowledge of project planning, critical path management, milestone management, budget control, risk management, issue management, and change management.

• 具备项目治理、阶段门管理、项目状态报告及管理决策支持经验。

Experience in project governance, stage-gate management, project reporting, and executive decision support.

• 熟悉GMP、药品注册法规及质量管理体系要求。

Familiarity with GMP requirements, regulatory frameworks, and quality management systems.

通用能力| Core Competencies

• 优秀的沟通协调能力和项目推动能力。

Excellent communication, stakeholder management, and project execution skills.

• 良好的逻辑分析能力、风险识别能力和问题解决能力。

Strong analytical thinking, risk identification, and problem-solving capabilities.

• 具备复杂矩阵组织环境下的跨部门协同经验。

Proven ability to work effectively within complex matrix organizations.

• 具备较强责任心、结果导向意识及抗压能力。

Strong sense of accountability, results orientation, and ability to work under pressure.

• 良好的中英文书面及口头沟通能力。

Strong verbal and written communication skills in both Chinese and English.

优先条件| Preferred Qualifications

• PMP认证或同类项目管理认证。

PMP certification or equivalent project management qualifications.

• 熟悉Microsoft Project、Planisware、Smartsheet、Jira、Veeva等项目管理系统。

Experience with project management systems such as Microsoft Project, Planisware, Smartsheet, Jira, or Veeva.

• 具有CRO/CDMO管理经验。

Experience managing CROs, CDMOs, and external strategic partners.

• 具有大型制药企业、跨国药企或创新药企业项目管理经验。

Experience in multinational pharmaceutical companies or innovative biotech organizations is preferred.