FA AD制剂开发副总监

Leadership 领导力 • Provide strategic direction and technical leadership for formulation development across multiple client programs and development stages. 制定制剂开发整体技术路线与发展战略，支持多客户、多阶段项目并行推进。 • Build, lead, mentor, and develop formulation development teams. 建设并管理制剂开发团队，持续提升团队能力。 • Define departmental goals, resource planning, capability development, and succession planning. 规划部门资源、能力建设和梯队发展。 • Establish and continuously improve formulation development platforms, standards, and best practices suitable for CDMO operations. 建立并持续优化适用于CDMO模式的制剂开发平台、标准流程和技术体系。 Site Safety and Environmental compliance 现场安全和环境合规 • Take a leadership role in site safety through promotion of safe work place and personal action; 通过促进安全工作场所和个人行动，在现场安全方面发挥领导作用; • Adhere to the Company’s safety and environmental protection procedures. 遵守公司的安全和环保程序。 Formulation & Process Development 制剂与工艺开发 • Oversee formulation development activities for drug substance (DS), and drug product (DP) of Monoclonal antibodies, bsAb, msAb, and complex recombinant proteins. 全面负责单抗，双抗，多抗及复杂重组蛋白的原液和制剂产品的处方开发工作。 • Ensure formulation robustness, manufacturability, and long-term stability suitable for clinical and commercial supply. 确保制剂方案具备良好的稳定性、工艺适应性和商业化可行性。 • Act as senior subject matter expert for complex formulation challenges, risk assessments, and troubleshooting. 作为制剂领域的高级专家，解决复杂技术问题并进行风险评估。 • Responsible for leading and coordinating technology transfer activities from development to GMP manufacturing. Ensures that processes, formulations, and control strategies are effectively transferred, implemented, and maintained to support clinical and commercial manufacturing. 主导并协调从研发到GMP生产的技术转移工作，确保工艺、制剂、及控制策略能够被准确、完整并可重复地转移、落地和执行，以支持临床及商业化生产。 Quality 质量要求 • Take part in Quality Management System documentation covering the development and tech transfer processes and procedures; 参与质量管理体系文件，包括开发和技术转让过程和程序; • Comply with the Company Quality Management System for development activities; 遵守公司质量管理体系的发展活动; • Serve as Subject Matter Expert for quality-issues related to formulation. 作为与配方相关的质量问题的主题专家。

Qualifications 任职资格 • Major in Pharmaceutics, Pharmaceutical Science or related field; 药学、药学或相关专业; • Advanced post-graduate qualification (MSc or PhD) related to bioprocessing or biopharmaceutical production. 生物加工或生物制药生产相关的高级研究生资格(MSc或PhD)。 Essential Experience必要经验 • MS degree with a minimum of 8 years and Ph.D. degree with a minimum of 5 years of pharmaceutical formulation experience; 硕士学位至少8年，博士学位至少5年的药物配方经验; • Experience in managing staff of at least 5 technical specialists; 至少5名技术专家的管理经验; • Expert knowledge in protein biochemistry related to protein formulation and characterization of MAbs and recombinant proteins; 具备蛋白质生物化学方面的专业知识，包括蛋白质配方、单克隆抗体和重组蛋白的鉴定; • Thorough practical knowledge of Chemistry Manufacturing and Controls for IND/CTA filing in China, USA and EU 具备在中国，美国和欧盟进行IND/CTA注册的化学制造和控制方面的实际知识。

职位描述

职位要求

Arthur Yang