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
Hengrui Pharma • Princeton, NJ, United States
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job_description.job_card.job_description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。 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. 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.
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：
Responsibilities :
Requirements :
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工艺开发研究员 — 恒瑞-全球精英计划 • Princeton, NJ, United States
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