Job Description

主要职责:

主要职责 / Key Responsibilities

一、工艺开发与优化 / Process Development & Optimization

• 负责哺乳动物/微生物细胞培养工艺开发与优化，包括培养基筛选、工艺参数研究、代谢调控等；
• Responsible for mammalian/microbial cell culture process development and optimization, including media screening, process parameter studies, and metabolic regulation.
• 主导小试/中试规模生物反应器（如STR、WAVE）的工艺开发及DOE实验设计；
• Lead lab/pilot-scale bioreactor (e.g., STR, WAVE) process development and DOE experimental design.

二、技术转移与项目申报 / Technology Transfer & Regulatory Submissions

• 建立完整的工艺开发技术文档（批记录、SOP、技术报告），支持IND/BLA申报；
• Establish comprehensive technical documentation (batch records, SOPs, technical reports) to support IND/BLA submissions.
• 参与技术转移至GMP生产部门，解决放大生产中的工艺问题；
• Participate in technology transfer to GMP manufacturing departments and resolve process-related issues during scale-up.

三、平台建设与管理 / Platform Development & Management

• 跟踪国内外细胞培养技术动态，评估新技术在工艺开发中的应用潜力；
• Monitor domestic and international technological trends in cell culture, and evaluate the potential application of new technologies in process development.
• 负责仪器的日常维护及其他细胞培养工艺开发相关的工作；
• Oversee daily instrument maintenance and other tasks related to cell culture process development.

任职资格：

教育背景：

• 硕士及以上学历，生物工程、生物技术、发酵工程等相关专业。
• Master’s degree or above in Bioengineering, Biotechnology, Fermentation Engineering, or related disciplines.

相关经验：

• 课题涉及细胞实验，熟悉CHO/HEK293等表达系统。
• Research projects involving cell culture experiments, with familiarity in CHO/HEK293 expression systems.

语言要求：

• 具备良好的英语听说读写能力，能够流畅阅读英文专业文献，与国际同行进行技术交流。
• Strong English proficiency (listening, speaking, reading, writing), capable of fluently interpreting English technical literature and conducting technical communication with international peers.

预期工作地点：

上海/苏州/广州/连云港

Shanghai / Suzhou / Guangzhou / Lianyungang

能力要求：

专业技能：

1. 掌握细胞培养、无菌操作等基础实验技能（有CHO/HEK293培养经验优先）；参与过细胞培养相关科研课题（如培养基优化、代谢流分析）优先；Proficient in fundamental experimental techniques (e.g., cell culture, aseptic operations); Priority given to candidates with CHO/HEK293 culture experience or involvement in cell culture-related research projects (e.g., media optimization, metabolic flux analysis).
2. 了解生物反应器工作原理，有摇床/小型生物反应器操作经验，熟悉生物反应器控制系统或自动化设备操作优先；Understanding of bioreactor operating principles; Preference for candidates with hands-on experience in shaker flasks/small-scale bioreactors or familiarity with bioreactor control systems/automated equipment.
3. 具备基础数据处理能力（Excel/JMP/Minitab）；Basic data analysis capabilities (Excel/JMP/Minitab).
4. 发表过相关领域SCI论文或专利优先。 Priority given to candidates with publication of SCI-indexed papers or patents in relevant fields.

通用能力：

1. 学习能力强，对生物制药工艺开发有浓厚兴趣；Strong learning agility and deep interest in biopharmaceutical process development.
2. 逻辑清晰，具备独立解决问题能力；Logical thinking and independent problem-solving skills.
3. 具备良好的跨部门协作意识。Strong cross-departmental collaboration mindset.

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