Job Description

工作职责

位置：苏州、广州、连云港

一、战略与技术领导力（Strategic & Technical Leadership）

1. 为整个工艺开发部门提供专业的科学指导与监督。
2. 制定并实施前瞻性的工艺开发（PD）战略，将先进技术融入下一代生物药及复杂分子的研发中。
3. 建立平台工艺，同时推动创新以解决分子特异性挑战（如产物相关杂质、聚集、复杂制剂的低表达量等问题）。

二、深度领域专业知识与监督（Deep Domain Expertise & Oversight）

1. 上游工艺开发（Upstream Process Development）

提供关于先进细胞培养技术的专业指导，包括高通量克隆筛选、培养基 / 补料优化、灌流工艺开发，以及通过过程强化策略实现业界领先的表达量和产品质量。

2. 下游工艺开发（Downstream Process Development）

针对复杂分子纯化工艺的挑战提供专业指导，包括平台工艺优化、新型色谱填料评估（如多模态色谱）以及设计稳健的病毒清除策略。需具备处理高粘度、低稳定性或异质性产物的深度专业知识。

三、CMC 整合（CMC Integration）

1. 担任工艺开发领域的最终技术决策者，确保与细胞系开发、分析开发和制剂团队的无缝衔接，共同界定关键质量属性（CQAs）并建立整体控制策略。

四、团队管理与发展（Team Management & Development）

1. 负责上游、下游及技术转移团队的领导、培养并激励，打造一只跨专业且高效的科学家与工程师团队。
2. 营造追求科学卓越、创新、负责任及持续学习的文化氛围。吸引、培养并留住全球顶尖人才。

五、技术转移与放大（Tech Transfer & Scale-Up）

1. 主导所有向内部 GMP（药品生产质量管理规范）生产基地及外部合作伙伴（合同开发生产组织，CDMOs）的技术转移战略监督工作。确保工艺具备可放大性、可重复性，并符合全球监管标准。
2. 在 GMP 生产过程中，为解决疑难问题提供专业支持。

六、全球监管战略（Global Regulatory Strategy）

1. 主导监管申报资料（IND、BLA、MAA）中工艺描述及其他核心章节的技术撰写与审核工作。
2. 制定工艺验证策略（工艺性能确认 PPQ），并在与监管机构沟通时为工艺参数范围提供充分的科学依据。

七、运营卓越（Operational Excellence）

1. 有效管理部门的预算、资源和时间节点。主导提升效率、降低生产成本（COGs）及实施新技术的各项计划。

任职资格

一、教育背景

拥有生物化学工程、化学工程、生物化学或相关专业博士学位。

二、相关经验

1. 需具备至少 15 年生物制剂工艺开发的持续深入经验，其中至少 8 年担任高级领导职务，负责管理经理层及大型多学科团队。
2. 必须具备深厚的实操技术专长，且需有经证实的业绩记录，包括：

• 为复杂分子（如双特异性抗体、ADC（抗体药物偶联物）、融合蛋白）开发并放大上游工艺，成功解决轻重链错配、产物异质性及低表达量等技术挑战。
• 为复杂分子开发并放大下游纯化工艺，具备解决蛋白聚集、产物相关杂质及特殊分离技术难题的实战经验。
• 优先考虑具备直接领导至少一种复杂生物药从晚期开发阶段至 BLA/MAA 申报获批全过程 CMC 开发的经验。
• 精通全球监管要求（美国 FDA、欧洲 EMA、ICH 指南），并具有直接与药品监管机构进行技术沟通的实际经验。

1. 具备建立、指导并领导世界级工艺开发团队的成功经验。

能力要求

1. 具备卓越的战略思维、问题解决及决策能力，注重基于数据的结果。
2. 具备出色的沟通及利益相关者管理能力，能够向高管层及跨职能合作伙伴清晰阐述复杂的技术概念。

English Job Description (JD)

Job Responsibilities

Location: Suzhou/ Guangzhou/ Lianyungang

1. Strategic & Technical Leadership

1. Provide expert scientific direction and oversight for the entire Process Development organization.
2. Develop and implement a forward-looking PD strategy that incorporates advanced technologies for next-generation biologics and complex molecules.
3. Establish platform processes while driving innovation to tackle molecule-specific challenges (e.g., product-related impurities, aggregation, low expression titers for complex formats).

2. Deep Domain Expertise & Oversight

1. Upstream Process Development

Provide expert guidance on advanced cell culture technologies, including high-throughput clone screening, media/feed optimization, perfusion process development, and process intensification strategies to achieve best-in-class titers and product quality.

2. Downstream Process Development

Provide expert guidance on purification process challenges specific to complex molecules, including platform process optimization, novel chromatography resin evaluation (e.g., multi-modal), and designing robust viral clearance strategies. Deep knowledge of handling high viscosity, low stability, or heterogeneous products is essential.

3. CMC Integration

1. Serve as the ultimate technical authority for Process Development, ensuring seamless integration with Cell Line Development, Analytical Development, and Formulation teams to define critical quality attributes (CQAs) and establish a holistic control strategy.

4. Team Management & Development

1. Lead, mentor, and inspire a large, high-performing team of scientists and engineers across upstream, downstream, and tech transfer functions.
2. Foster a culture of scientific excellence, innovation, accountability, and continuous learning. Attract, develop, and retain top-tier global talent.

5. Tech Transfer & Scale-Up

1. Own the strategic oversight of all technology transfers to internal GMP manufacturing sites and external partners (CDMOs). Ensure processes are scalable, reproducible, and compliant with global regulatory standards.
2. Provide expert troubleshooting support during GMP manufacturing campaigns.

6. Global Regulatory Strategy

1. Lead the technical authorship and review of the Process Description and other critical sections of regulatory filings (IND, BLA, MAA).
2. Define the process validation strategy (PPQ) and provide strong scientific justification for process parameter ranges during health authority interactions.

7. Operational Excellence

1. Manage the department’s budget, resources, and timelines effectively. Champion initiatives to improve efficiency, reduce COGs, and implement new technologies.

Qualifications

1. Education Background

Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, or a directly related field.

2. Relevant Experience

1. Minimum of 15 years of extensive and progressive experience in biologics process development, with at least 8 years in a senior leadership role managing managers and large, multi-disciplinary teams.
2. Deep, hands-on technical expertise is non-negotiable. Must have a proven track record of:

• Developing and scaling upstream processes for complex molecules (e.g., bispecifics, ADCs, fusion proteins) addressing challenges like chain mispairing, product heterogeneity, and low expression.
• Developing and scaling downstream purification processes for complex molecules, with proven experience in solving challenges related to aggregation, product-related impurities, and unique separation techniques.
• Direct experience leading the CMC development of at least one complex biologic molecule from late-stage development through to BLA/MAA submission and approval is highly desired.
• Expert knowledge of global regulatory requirements (FDA, EMA, ICH) and experience interacting directly with health authorities.

1. Demonstrated success in building, mentoring, and leading a world-class process development organization.

Competency Requirements

1. Exceptional strategic thinking, problem-solving, and decision-making skills, with a focus on data-driven outcomes.
2. Outstanding communication and stakeholder management skills, with the ability to articulate complex technical concepts to executive leadership and cross-functional partners.

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