DS Associate Director/Director (MJ016947)

负责原液生产车间的全面生产管理;从新设施启动、C&Q执行到cGMP生产;持续优化生产流程;并确保生产过程符合GMP标准;实现高效合规运营。

Main Responsibilities 主要职责:

610202 02Fully lead and manage clinical and commercial production activities in the drug substance workshops based on established production plans to ensure the achievement of production goals.

根据既定的生产计划;全面领导并管理抗体原液生产车间的临床及商业生产活动;确保生产目标的达成。

610202 02Lead the drug substance production team, including staff recruitment, training, and career development; coordinate effective communication and collaboration with relevant departments to enhance overall team efficiency.

领导抗体原液车间生产团队;包括人员招聘、培训和人员培养;协调与生产相关部门的有效沟通与合作;提升团队整体效能。

610202 02Ensure that production activities strictly adhere to cGMP, EHS, and data integrity requirements, establish and strengthen a culture of compliance.

确保生产活动严格遵守cGMP、EHS和数据完整性要求;建立并强化合规文化。

610202 02Be responsible for the management of equipment and facilities in the drug substance workshop, including C&Q and calibration of process equipment and systems, ensuring these activities proceed as planned.

负责抗体原液车间设备、设施的管理。包括工艺设备和系统的C&Q和校验等工作;确保按计划进行。

610202 02Establish and continuously optimize clinical and commercial production systems, organize implement, and supervise the ongoing effective operation of the production quality system.

建立并不断优化临床及商业化生产体系;组织实施并监督生产质量体系的持续有效运行。

610202 02Plan and purchase necessary equipment, instruments, and materials for production to ensure smooth validation and production processes.

计划和采购生产所需的设备、仪器和物料;确保验证与生产的顺利进行。02

610202 02Complete other tasks assigned by superiors.

完成上级安排的其他工作。

02

Education/ Professional Qualification

学历/专业资格

Bachelor or above degree in Pharmacy, Biology, Chemistry, etc.

本科或以上学历; 药学;生物学或化学专业。

Technical/Skills Required

技术/技能需求

Familiar with manufacturing of biological products, familiar with GMP/GLP requirements, with experience in stainless production preferred.

熟悉生物制药产品生产;熟悉GMP/GLP 相关要求，有生物制品不锈钢系统生产经验者优先。

Familiar with the regulatory requirement of NMPA cGMP、EU cGMP、PIC/S cGMP and FDA cGMP.

熟悉NMPA cGMP、EU cGMP、PIC/S cGMP 及FDA cGMP 的要求。

Working Experience

工作经验02

At least 10 years manufacturing experience of manufacturing products and at least 7 years manufacturing managerial roles.

医药行业10 年以上生物制药生产经验;7年以上生产管理经验。

Language, Computer Literacy, Office Software, etc.

语言能力;电脑知识;办公软件等

Proficient in English and computer skill.

英语水平良好;会熟悉使用电脑。

Others

其他02

Competent in organization and coordination, team leadership, analytical skills and problem solving.

有较强的组织协调能力;良好的团队领导力;较强的分析和解决问题的能力。

Good communication skills.

具有良好的沟通表达能力。

02

百济神州全球胜任力

当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。

●团队协作

●提供并征求坦诚及可行的反馈

●自我认知

●兼容并蓄

●积极主动

●开拓精神

●持续学习

●拥抱变化

●结果导向

●分析性思维/数据分析

●卓越财务

●清晰沟通

BeiGene Global Competencies

When we exhibit our values of Patients ***, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

●Fosters Teamwork

●Provides and Solicits Honest and Actionable Feedback

●Self-Awareness

●Acts Inclusively

●Demonstrates Initiative

●Entrepreneurial Mindset

●Continuous Learning

●Embraces Change

●Results-Oriented

●Analytical Thinking/Data Analysis

●Financial Excellence

●Communicates with Clarity

求职者隐私申明：

百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。

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If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeiGene Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.

关键字：

gmp

生产管理

生产流程