1. 協調法規相關部門與供應商評價授權產品
2. 評估產品於亞太地區註冊之可行性，準備註冊所需相關技術文件與試驗
3. 在產品開發及送件準備期間提供法規要求的指引，協助其符合國際法規…
職缺專區
1. Review and provide the technical recommendations for CMC documentation and Common Technical Document(CTD) dossier from a regulatory…
待遇面議
This position is located at Lotus Taipei office and work closely with global RA team mainly take care in-licensing projects. The ideal candidate has strong RA experience with Asia or South East Asia region new submission and life-cycle production management…
待遇面議
1. Review and provide the technical recommendations for CMC documentation and Common Technical Document(CTD) dossier from a regulatory…
待遇面議
1. Process review
2. Process development & optimization
3. Scale up
4. Technology transfer to production
5. Impurity profile establishment..
2. Process development & optimization
3. Scale up
4. Technology transfer to production
5. Impurity profile establishment..
待遇面議
1. Expertise in protein drug production / purification (ex: SEC, HIC, IEX chromatography and diafiltration of antibody) /or small molecules synthesis (MW<5,000)
2. Experience in process development, optimization, and scale up of proteins /or small molecules.
3. Ability to transfer technology to GMP production and troubleshoot issues…
2. Experience in process development, optimization, and scale up of proteins /or small molecules.
3. Ability to transfer technology to GMP production and troubleshoot issues…
