【职缺名称】Sr. Scientist 【徵才单位】喜康生技 【工作地址】竹北 【工作内容】 1. Requires a PhD in Chemical/Biochemical Engineering, Biochemistry, Cell Biology, or related discipline and 1+ year of relevant experience or a Master degree in related discipline with 4+ years of relevant experience 2. Strong Scientific and Engineering expertise developing novel upstream mammalian cell culture processes for the generation of monoclonal antibody and recombinant protein therapeutic products. 3. Expertise in optimization of cell culture processes to manipulate product quality characteristics as well as productivity 4. Experience with CHO-based expression systems highly desirable 5. Extensive hands-on expertise with laboratory procedures and operations including set up and operating shake flasks, lab scale bioreactors and pilot scale bioreactors and associated analytical techniques used for mammalian cell culture processes 6. Experience with single use bioreactors (SUBs) highly desirable 7. Expertise leading media and feed development, scale-up, technology transfer and process validation activities 8. Experience with cGMP’s highly desirable 9. Experience authoring IND, CTA, and BLA regulatory documents highly desirable 10. Excellent written, oral and organizational skills 11. Detailed knowledge and experience in developing submission strategy and regulatory filing. 12. Written and oral communication in Mandarin and English are essential. 【徵才条件】 1. Design, execute and evaluate laboratory-scale cell culture experiments in order to develop robust processes suitable for GMP clinical and commercial manufacturing 2. Process development scope includes clone screening in bioreactors, media and feed development, defining optimal ranges for bioreactor operation and control parameters 3. Develop phase-appropriate characterization and validation strategies for the developed processes 4. Implement sound statistical DOE-based studies for efficient process optimization and characterization 5. Seek out, evaluate, and implement new technologies to optimize efficient development of cell culture processes 6. Develop and maintain necessary process development documentation standards including process development reports, technical transfer reports, and characterization and validation protocols, as well as laboratory equipment data capture and storage. 7. Support process transfer into manufacturing and lead process validation at scale 8. Write and revise protocols, procedures, reports and other process related documentation as necessary to support GMP manufacturing operations 9. Author cell culture sections of regulatory submission documents for world-wide health authorities 【薪资待遇】面议 【联络方式】[email protected] 萧小姐 【其他备注】请自备中英文履历自传 有问题可以站内信问我....... --

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