DSPD FL 下游工艺开发项目负责人 - 无锡 Wuxi

岗位目标 对下游 DSPD 项目进行端到端负责，确保在既定成本、周期与质量标准下完成客户/内部里程碑交付；作为项目负责人，能够高效推进跨团队协作，识别与管理风险，并推动关键决策达成。

1. 01

   项目交付与计划管理 负责下游项目从启动到交付的全流程管理：明确项目范围（scope）、关键交付物、关键路径及里程碑，建立并持续更新项目计划（包含资源/FTE需求）。 对项目关键交付结果负责，包括但不限于：实验方案设计、数据完整性与质量、开发报告、工艺策略输出及客户沟通材料。 持续识别项目执行过程中的风险与偏差，及时推动问题解决及决策升级，确保项目按计划交付。

2. 02

   技术策略与实验执行 基于对 CMC 全流程的理解，制定下游纯化工艺开发策略及整体timeline，并推动策略有效执行。 负责关键工艺开发决策，包括填料筛选、新技术应用、关键工艺参数定义、工艺稳健性评估及放大策略制定。 识别生产放大过程中的关键技术难点与风险点（如收率、纯度、聚集体、HCP/DNA、病毒安全性及放大风险等），推动制定解决方案并组织实施。 与相关职能团队（分析、上游、生产等）紧密协作，确保技术路径与数据结果的一致性与可执行性。

3. 03

   跨团队协作与客户沟通 作为下游项目对内/对外的主要接口，协同上游（CCPD）、分析（AS）、技术转移（MSAT）、生产（MFG）等团队，推进工艺开发及放大工作的顺利实施。 组织并主导客户沟通，包括需求澄清、技术方案对齐、关键风险识别与升级、关键结论输出等，提升客户满意度与信任度。 在跨团队合作过程中主动推动问题闭环及资源协调，确保整体项目交付效率

Qualifications（优先条件） 具备商业化或后期项目经验，如 PPQ 支持、GMP 技术转移、申报支持（IND/BLA模块资料等）； 有客户审计或监管检查支持经验； 具备建模/统计/数字化能力（如 DoE、数据分析自动化或流程数字化项目经验）； 具备团队管理或项目统筹经验，能够同时推进多个项目交付。 其他要求（Other Requirements） 扎实的下游工艺与纯化平台知识：Protein A、离子交换、疏水、混合模式、病毒灭活/过滤、UF/DF 等，并理解 DoE、工艺表征及放大逻辑； 良好的中英文沟通与书面表达能力，能够独立组织客户会议并撰写会议纪要、技术报告及总结材料； 具备质量与合规意识，熟悉 GMP 基本要求及偏差/变更/调查逻辑（深度可按岗位级别区分）； 具备数据驱动的分析能力，能够基于数据支持项目决策与管理汇报。 Job Responsibilities Role Objective End-to-end accountability for downstream DSPD projects, ensuring the delivery of client/internal milestones within defined cost, timeline, and quality standards. As the project lead, efficiently drive cross-functional collaboration, identify and manage risks, and facilitate critical decision-making.

1. 01

   Project Delivery & Planning Management Responsible for full lifecycle management of downstream projects from initiation to delivery: define project scope, key deliverables, critical path, and milestones; establish and continuously update project plans (including resource/FTE requirements). Accountable for key project deliverables, including but not limited to: experimental protocol design, data integrity and quality, development reports, process strategy outputs, and client communication materials. Continuously identify risks and deviations during project execution; proactively drive issue resolution and escalation to ensure on-time project delivery.

2. 02

   Technical Strategy & Experimental Execution Based on a comprehensive understanding of the CMC lifecycle, develop downstream purification process development strategies and overall timelines, and drive effective execution of such strategies. Responsible for key process development decisions, including resin screening, new technology application, critical process parameter definition, process robustness assessment, and scale-up strategy formulation. Identify key technical challenges and risks during manufacturing scale-up (e.g., yield, purity, aggregates, HCP/DNA, viral safety, and scale-up risks), drive the development of solutions, and oversee their implementation. Collaborate closely with relevant functional teams (Analytical, Upstream, Manufacturing, etc.) to ensure consistency and executability of technical approaches and data outcomes.

3. 03

   Cross-functional Collaboration & Client Communication Serve as the primary internal and external interface for downstream projects; coordinate with Upstream (CCPD), Analytical Sciences (AS), Manufacturing Science and Technology (MSAT), Manufacturing (MFG), and other teams to facilitate smooth process development and scale-up activities. Organize and lead client communications, including requirements clarification, technical alignment, key risk identification and escalation, and delivery of key conclusions, to enhance client satisfaction and trust. Proactively drive issue closure and resource coordination in cross-functional collaborations to ensure overall project delivery efficiency. Preferred Qualifications Experience with commercial or late-stage projects, such as PPQ support, GMP technology transfer, or regulatory filing support (IND/BLA module documentation, etc.). Experience supporting client audits or regulatory inspections. Modeling/statistical/digital capabilities (e.g., DoE, data analysis automation, or process digitalization project experience). Team management or project coordination experience, with the ability to simultaneously advance multiple project deliveries. Other Requirements Solid knowledge of downstream process and purification platforms: Protein A, ion exchange, hydrophobic interaction, mixed-mode chromatography, viral inactivation/filtration, UF/DF, etc., with an understanding of DoE, process characterization, and scale-up logic. Strong communication and written expression skills in both Chinese and English; capable of independently organizing client meetings and drafting meeting minutes, technical reports, and summary materials. Quality and compliance awareness; familiarity with basic GMP requirements and deviation/change/investigation logic (depth may vary by position level). Data-driven analytical capabilities; able to support project decisions and management reporting based on data.