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工艺开发研究员 — 恒瑞-全球精英计划
工艺开发研究员 — 恒瑞-全球精英计划Hengrui Pharma • Princeton, NJ, United States
工艺开发研究员 — 恒瑞-全球精英计划

工艺开发研究员 — 恒瑞-全球精英计划

Hengrui Pharma • Princeton, NJ, United States
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工作地点：上海

岗位职责 :

  • 负责生物药（单抗、双抗、融合蛋白等）上游 / 下游工艺开发与优化，包括但不限于细胞培养、纯化工艺开发。
  • 负责新型工艺平台的开发与探索，包括连续生产、高密度培养、PAT技术等
  • 参与工艺技术转移（Tech Transfer），并提供放大生产支持。
  • 负责起草相关技术文档，支持IND / BLA申报。
  • 遵循GLP（良好实验室规范）要求开展实验方案制定、数据记录与分析，确保研发过程的可追溯性和合规性。
  • 参与实验室日常5S运营与维护。

任职要求：

  • 硕士及以上学历，生物工程、生物技术、化学工程、制药工程或相关专业。
  • 具有哺乳动物细胞培养或蛋白纯化操作经验优先。
  • 熟悉DoE（实验设计）等统计工具，具备工艺建模及数据分析能力（JMP / Minitab等）。
  • 了解国内外生物药相关法规（ICH / USP / EP）及行业指导原则（如QbD理念）。
  • 具有较强的文献检索，分析和问题解决能力。
  • 具有良好团队协作精神和跨部门沟通能力。

    • Responsibilities :

  • Responsible for upstream / downstream biopharmaceutical process development and optimization (including but not limited to cell culture and purification processes) for monoclonal antibodies, bispecific antibodies, fusion proteins, etc.
  • Explore and develop novel process platforms, including continuous processing, high-density cell culture, and Process Analytical Technology (PAT).
  • Participate in process technology transfer (Tech Transfer) and provide scale-up manufacturing support.
  • Prepare relevant technical documents to support IND / BLA filings.
  • Conduct experiments in compliance with GLP (Good Laboratory Practice) requirements, ensuring traceability and regulatory compliance in R&D processes.
  • Participate in laboratory 5S operations and maintenance.

    • Requirements :

  • Master’s degree or higher in Bioengineering, Biotechnology, Chemical Engingeering, Pharmaceutical Engineering, or related fields.
  • Hands-on experience in mammalian cell culture or protein purification is preferred.
  • Familiarity with statistical tools such as DoE (Design of Experiments) and proficiency in process modeling and data analysis (JMP, Minitab, etc.).
  • Knowledge of global biopharmaceutical regulations (ICH, USP, EP) and industry guidelines (e.g., QbD principles).
  • Excellent literature search capabilities coupled with analytical thinking and problem-solving skills
  • Excellent teamwork and cross-functional communication abilities.
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    工艺开发研究员 — 恒瑞-全球精英计划 • Princeton, NJ, United States