Job Responsibilities 工作職責:
1.Responsible for process development of purification (mAb, BsAb, etc), including but not limited to chromatography, filtration, UFDF, stability studies, etc.
負責純化(單抗,雙抗等)的工藝開發,包括但不限于層析、過濾、超濾透析、穩定性研究等;
2.Conduct process development and process optimization experiment, including resin screening, filter sizing, buffer sizing, DOE, etc.
執行工藝開發和工藝優化實驗,包括填料篩選,濾器選型,緩沖液篩選, DOE等;
3.Responsible for managing technical documents including operating procedures, protocols, reports, risk assessments, laboratory investigations, etc.
負責管理技術文件包括操作規程,方案,報告,風險評估,實驗室調查等;
4.Responsible for data analysis, data review and trend analysis.
負責數據分析,數據審核和趨勢分析;
5.Provide technology support for production of MFG, assist in troubleshooting and solving problems.
對MFG的生產提供技術支持,并協助排查與解決問題;
6.According to the production process, review the relevant GMP production documents.
根據生產工藝,審閱相關GMP生產文件;
7.Summary change control of owner each project, Optimize and improve processes, improve efficiency.
總結每個項目的變更控制,并優化和改善工藝,提高效率;
8.Communicate effectively with the company’s internal and external departments to successfully complete the project on time.
與公司內外各部門進行有效溝通,順利推動項目按時完成;
9.Other work arranged by superior leaders.
上級領導安排的其他工作。
Qualification 任職資格:
1.Master's degree in life Sciences / Chemistry / Pharmacology or bachelor's degree with three years or more experience in protein purification.
生命科學/化學/藥學相關專業的碩士或具有三年及以上從事相關蛋白純化工作經驗的本科學歷;
2.3+ year of related experience in purification field.
三年及以上從事相關蛋白純化工作經驗;
3.Thorough knowledge and understanding of biopharmaceutical technology, processes.
對生物制藥技術、工藝有較深入的知識和認識;
4.Capable of writing detailed reports and summaries and exhibit detail-oriented documentation skills.
擅長撰寫各種詳細的報告摘要和注重細節的文檔報告;
5.Familiarity of computer-based systems.
熟悉電腦操作;
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.
良好的中英文讀寫和溝通能力,可與其他部門進行溝通解決問題;
7.Must be flexible to work on any shift (day, night, weekend).
適合彈性的工作時間,愿意配合加班。