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蛋白纯化高级研究员
7-8K/月湖北省-武汉/硕士及以上/3-5年
余颖一周前来过
杭州锐致商务咨询有限公司
职位详情
岗位职责
任职要求：
1. Master’s Degree in Life Sciences/Chemistry/Pharmacology and 3+ year of related experience in purification;
生命科学/化学/药学相关专业的硕士，具有三年及以上从事相关蛋白纯化工作经验；
2. Have certain knowledge and understanding of biopharmaceutical technology, processes;
对生物制药技术、工艺有一定的知识和认识；
3. Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills;
擅长撰写各种报告摘要和文档报告；
4. Familiarity of computer-based systems;
熟悉电脑操作；
5. Must be flexible to work on any shift (day, night, weekend);
适合弹性的工作时间，愿意配合加班；
6. Excellent oral and written communication skills in Chinese and English (Read, Write, Verbal) demonstrated by communicating with other functions and management regarding resolving investigations and theory.
良好的中英文读写和沟通能力，可与其他部门进行沟通解决问题。
7. Clear thinking and good critical thinking；
思路清晰，思辨能力好；
8. Have positive attitude and full of positive energy;
心态阳光，充满正能量；
9. Have a certain research spirit, good team-work sense and strong ability to work under pressure;
有一定的专研精神，良好的团队意识和较强的抗压能力；
10. Have good team-work sense and strong ability to work under pressure。
良好的团队意识和较强的抗压能力。
岗位职责：
1.Do the preparatory work before the start of the experiment or pilot production. (e.g.: the preparation of BR, materials, labels, TAR and so on.).
完成实验或中试生产前的准备工作（如批记录起草、物料、标签、请检单等）；
2.According to the process of Sending Unit, complete process transfer and scale-up at different scale, and transfer the process to the manufacturing department finally.
按照转移方转移的工艺，完成不同规模的工艺转移和放大，并最终将工艺转移到生产部门；
3.Perform the development/optimization of process transfer and scale-up, and troubleshooting the difficult problems encountered during manufacturing.
完成工艺转移和放大过程中的开发/优化，并解决生产过程中遇到的疑难问题；
4.Draft process transfer related documents and reports, review and revise project related GMP documents.
起草工艺转移相关文件和报告，并审阅和修改项目相关GMP文件；
5.Make the appropriate experimental records during the experiments as required, cooperate with the teammate to execute pilot scale protein purification process in accordance with batch records.
试验期间按要求记录试验记录，和团队成员按照批次记录中试蛋白纯化过程；
6.Freezer management. (Including 4℃，-20℃，-80℃ Freezer), timely completion of qualification and calibration of instruments and equipment.
管理4℃，-20℃，-80℃冰箱，及时完成仪器和设备的确认和校准；
7.Summary experience of owner each project, optimize and improve processes, improve efficiency.
总结每个项目的经验，并优化和提高生产效率；
8.Conduct 50-200L pilot production in accordance with approved procedures, batch production records and plans.
按照批准的规程、批生产记录和方案，完成50-200L的中试生产；
9.Find potential problems during process scale-up, feedback and seek solutions with project owner in time.
发现工艺放大过程中的潜在问题，并及时与项目负责人反馈和寻求解决方案；
10.Complete relevant records in time as required.
按要求及时完成相关记录；
11.Summarize the problems encountered during the pilot production of each project, and optimize and improve production efficiency.
总结每个项目中试过程遇到的问题，并优化和提高生产效率；
12.Prepare the process characterization plan according to process.
按照生产工艺准备工艺表征方案；
13.Conduct risk assessment to determine process characterization experimental strategy.
进行风险评估来确定工艺表征实验策略；
14.Conduct the downstream purification process characterization as per approved protocol.
按照批准的方案执行下游纯化工艺表征工作；
15.Make the appropriate experimental records during the experiments.
试验期间按要求记录试验记录；
16.Do DOE design according to requirements and analyze data with common statistical software (such as JMP).
根据需求进行DOE设计，并用常用统计软件（如JMP）进行数据分析；
17.Complete the process characterization report in time.
及时完成相关工艺表征报告的撰写；
18.Participate in a series of related training (operation training and documentation training).
参加操作和文件相关的培训；
19. Other work arranged by superior leaders.
上级领导安排的其他工作。
1. Master’s Degree in Life Sciences/Chemistry/Pharmacology and 3+ year of related experience in purification;
生命科学/化学/药学相关专业的硕士，具有三年及以上从事相关蛋白纯化工作经验；
2. Have certain knowledge and understanding of biopharmaceutical technology, processes;
对生物制药技术、工艺有一定的知识和认识；
3. Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills;
擅长撰写各种报告摘要和文档报告；
4. Familiarity of computer-based systems;
熟悉电脑操作；
5. Must be flexible to work on any shift (day, night, weekend);
适合弹性的工作时间，愿意配合加班；
6. Excellent oral and written communication skills in Chinese and English (Read, Write, Verbal) demonstrated by communicating with other functions and management regarding resolving investigations and theory.
良好的中英文读写和沟通能力，可与其他部门进行沟通解决问题。
7. Clear thinking and good critical thinking；
思路清晰，思辨能力好；
8. Have positive attitude and full of positive energy;
心态阳光，充满正能量；
9. Have a certain research spirit, good team-work sense and strong ability to work under pressure;
有一定的专研精神，良好的团队意识和较强的抗压能力；
10. Have good team-work sense and strong ability to work under pressure。
良好的团队意识和较强的抗压能力。
岗位职责：
1.Do the preparatory work before the start of the experiment or pilot production. (e.g.: the preparation of BR, materials, labels, TAR and so on.).
完成实验或中试生产前的准备工作（如批记录起草、物料、标签、请检单等）；
2.According to the process of Sending Unit, complete process transfer and scale-up at different scale, and transfer the process to the manufacturing department finally.
按照转移方转移的工艺，完成不同规模的工艺转移和放大，并最终将工艺转移到生产部门；
3.Perform the development/optimization of process transfer and scale-up, and troubleshooting the difficult problems encountered during manufacturing.
完成工艺转移和放大过程中的开发/优化，并解决生产过程中遇到的疑难问题；
4.Draft process transfer related documents and reports, review and revise project related GMP documents.
起草工艺转移相关文件和报告，并审阅和修改项目相关GMP文件；
5.Make the appropriate experimental records during the experiments as required, cooperate with the teammate to execute pilot scale protein purification process in accordance with batch records.
试验期间按要求记录试验记录，和团队成员按照批次记录中试蛋白纯化过程；
6.Freezer management. (Including 4℃，-20℃，-80℃ Freezer), timely completion of qualification and calibration of instruments and equipment.
管理4℃，-20℃，-80℃冰箱，及时完成仪器和设备的确认和校准；
7.Summary experience of owner each project, optimize and improve processes, improve efficiency.
总结每个项目的经验，并优化和提高生产效率；
8.Conduct 50-200L pilot production in accordance with approved procedures, batch production records and plans.
按照批准的规程、批生产记录和方案，完成50-200L的中试生产；
9.Find potential problems during process scale-up, feedback and seek solutions with project owner in time.
发现工艺放大过程中的潜在问题，并及时与项目负责人反馈和寻求解决方案；
10.Complete relevant records in time as required.
按要求及时完成相关记录；
11.Summarize the problems encountered during the pilot production of each project, and optimize and improve production efficiency.
总结每个项目中试过程遇到的问题，并优化和提高生产效率；
12.Prepare the process characterization plan according to process.
按照生产工艺准备工艺表征方案；
13.Conduct risk assessment to determine process characterization experimental strategy.
进行风险评估来确定工艺表征实验策略；
14.Conduct the downstream purification process characterization as per approved protocol.
按照批准的方案执行下游纯化工艺表征工作；
15.Make the appropriate experimental records during the experiments.
试验期间按要求记录试验记录；
16.Do DOE design according to requirements and analyze data with common statistical software (such as JMP).
根据需求进行DOE设计，并用常用统计软件（如JMP）进行数据分析；
17.Complete the process characterization report in time.
及时完成相关工艺表征报告的撰写；
18.Participate in a series of related training (operation training and documentation training).
参加操作和文件相关的培训；
19. Other work arranged by superior leaders.
上级领导安排的其他工作。
任职要求
无
工作地点
- 东湖新技术产业开发区
