Hengrui Pharma
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.
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.