MST高级制剂工程师 (MJ019409)

610202 02Lead process deviations, investigations and CAPAs and make recommendations to Quality Assurance.02

领导工艺偏差、调查和CAPAs，并对质量保证提出建议。02

610202 02Lead the process optimization project, or provide optimization measures and suggestions to the process02

领导工艺优化项目，或对工艺提出优化措施和建议。02

610202 02Review essential elements of scale-up and technology transfer leading to a successful process validation and a robust commercialization.02

审阅扩大生产规模和技术转移的基本要素，从而实现成功的工艺验证和稳健的商业化。02

610202 02Gather knowledge as the basis for the manufacturing control strategy, the approach for process qualification and continuous process improvements.02

收集相关知识，作为制造控制策略、过程验证和持续过程改进的方法的基础。02

610202 02Author and review sections for different regulatory documents and submissions.02

为不同的法规文件和提交文件撰写和审查相关章节。02

610202 02Support and participate GMP inspection.02

支持并参与GMP检查02

610202 02Responsible for early and late clinical technology transfer projects.02

负责临床早期和后期的技术转移项目。02

610202 02Product lifecycle management02

产品的生命周期管理。02

610202 02Any other assignment as is determined by supervisor.02

完成上级安排的其他工作。02

Education/ Professional Qualification

学历/专业资格

BS, MS, PhD degree in Chemical Engineering, Pharmaceutics, or related field.02

化学工程、药学或相关专业本科、硕士或博士学历。02

Technical/Skills Required

技术/技能需求

1.0202 02Good GMP knowledge.02

良好的GMP知识。02

2.0202 02Knowledge of particle control, sterility assurance, single-use materials E/L study, sterile filtration process validation and other related knowledge.02

了解制剂工艺过程可见微粒控制，无菌保证，一次性耗材相容性研究，除菌过滤工艺验证等相关知识。02

3.0202 02Familiar with the production controls and studies of biological drugs in different clinical stages, familiar with the process and related work of DP technology transfer.02

熟悉生物药品在不同临床阶段的生产控制要求和研究内容，熟悉制剂技术转移的流程和相关工作。02

4.0202 02Familiar with process validation and its different stages of focus and purpose and have rich practical experience in process validation.02

熟悉工艺验证及其不同阶段的侧重点和目的，并具有丰富的工艺验证实践经验。02

5.0202 02Good skill in drafting GMP documents (both in Chinese and English), including but not limited to process validation, study protocols and reports, SOPs, etc.02

具备良好的GMP文件（中英文）起草能力，包括但不限于工艺验证、研究方案和报告，SOP等。02

6.0202 02Be able to conduct relevant studies independently in the Lab, including protocol drafting, training, equipment use, data analysis, report preparation, etc.02

可独立在实验室开展相关研究，包括研究方案起草、培训、设备使用、数据分析、报告准备等。02

7.0202 02Team Player with excellent interpersonal skills, also can demonstrate good team management skills. 02

良好的团队合作精神，良好的人际关系和团队管理能力。02

8.0202 02Good interdepartmental communication, coordination and organization skills02

具有良好的跨部门沟通协调和组织能力。

Working Experience

工作经验02

1.0202 02At least 5 years of practical experience in liquid and lyophilized DP for bachelor's degree, at least 3 years of practical experience in liquid and lyophilized DP for master's degree, and at least 2 years of practical experience in liquid and lyophilized DP for PhD.02

本科至少需5年以上液体和冻干制剂生产经验，硕士至少需3年以上液体和冻干制剂生产经验，博士至少需2年以上液体和冻干制剂生产经验。02

2.0202 02Experience with related technical support for parenteral drug product formulation and filling.02

有非肠道药物产品配方和灌装的相关技术支持的经验。02

3.0202 02Experience with related technical support for secondary packaging process validation、process controls02

有制剂包装工艺验证、过程控制的相关技术支持经验02

4.0202 02Familiar with GMP requirements, experience on addressing Deviations, Change control, CAPA, and related issues. 熟知GMP要求，有处理偏差、变更控制、CAPA及相关事件的经验。02

5.0202 02Rich practical experience in process validation and related DP process studies.02

具有丰富的工艺验证实践经验。02

6.0202 02Experience in GMP inspection.02

有参与GMP检查的经验。02

7.0202 02Good experience in drafting GMP documents (both in Chinese and English), including but not limited to process validation, study protocols and reports, SOP, etc.02

具有良好的GMP文件（中英文）起草起草经验，包括但不限于工艺验证、研究方案和报告，SOP等。02

8.0202 02Fluent written and oral DP technical communication skills in English is preferred.02

具有流利的英文书面和口头制剂技术沟通经验者优先02

9.0202 02The working experience for outstanding candidates can be appropriately relaxed

优秀候选人可适当放宽工作经验

Language, Computer Literacy, Office Software, etc.

语言能力，电脑知识，办公软件等

Good reading & writing in both English and Chinese; Excellent computer skills. Proficient in PPT, Excel, Word, Visio and other office software.02

良好的英语读写能力和计算机技能，可熟练使用PPT， Excel, Word, Visio等办公软件

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

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