上游工艺研究员 — 恒瑞-全球精英计划 Job at Hengrui Pharma, Boston, MA

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  • Hengrui Pharma
  • Boston, MA

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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