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SD/AVP of Biologics Process Development— 恒瑞-全球精英计划
SD/AVP of Biologics Process Development— 恒瑞-全球精英计划Hengrui Pharma • Princeton, NJ, United States
SD / AVP of Biologics Process Development— 恒瑞-全球精英计划

SD / AVP of Biologics Process Development— 恒瑞-全球精英计划

Hengrui Pharma • Princeton, NJ, United States
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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）

  • 为整个工艺开发部门提供专业的科学指导与监督。
  • 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。
  • 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）

  • 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）

  • 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。
  • 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）

  • 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。
  • 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）

  • 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。
  • 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）

  • 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

  • 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。
  • 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。
  • 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

  • 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。
  • 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

  • Provide expert scientific direction and oversight for the entire Process Development organization.
  • Develop and implement a forward-looking PD strategy that incorporates advanced technologies for next-generation biologics and complex molecules.
  • 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

  • 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

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

    • 5. Tech Transfer & Scale-Up

  • 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.
  • Provide expert troubleshooting support during GMP manufacturing campaigns.

    • 6. Global Regulatory Strategy

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

    • 7. Operational Excellence

  • 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

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

    • Competency Requirements

  • Exceptional strategic thinking, problem-solving, and decision-making skills, with a focus on data-driven outcomes.
  • 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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