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Sr. Engineer / Sr. Scientist, Cell Culture Process Development (Taiwan)

Summary

 Sr. Engineer / Sr. Scientist, Cell Culture Process Development (Taiwan)

Job Responsibilities

 l   Design, execute and evaluate laboratory-scale cell culture experiments in order to develop robust processes suitable for GMP clinical and commercial manufacturing

l   Process development scope includes clone screening in bioreactors, media and feed development, defining optimal ranges for bioreactor operation and control parameters

l   Develop phase-appropriate characterization and validation strategies for the developed processes

l   Implement sound statistical DOE-based studies for efficient process optimization and characterization

l   Seek out, evaluate, and implement new technologies to optimize efficient development of cell culture processes

l   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.

l   Support process transfer into manufacturing and lead process validation at scale

l   Write and revise protocols, procedures, reports and other process related documentation as necessary to support GMP manufacturing operations

l   Author cell culture sections of regulatory submission documents for world-wide health authorities

Job Qualifications (Education, Certifications, Experience)

 l   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

l   Strong Scientific and Engineering expertise developing novel upstream mammalian cell culture processes for the generation of monoclonal antibody and recombinant protein therapeutic products.

l   Expertise in optimization of cell culture processes to manipulate product quality characteristics as well as productivity

l   Experience with CHO-based expression systems highly desirable

l   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

l   Experience with single use bioreactors (SUBs) highly desirable

l   Expertise leading media and feed development, scale-up, technology transfer and process validation activities

l   Experience with cGMP’s highly desirable

l   Experience authoring IND, CTA, and BLA regulatory documents highly desirable

l   Excellent written, oral and organizational skills

l   Detailed knowledge and experience in developing submission strategy and regulatory filing.

l   Written and oral communication in Mandarin and English are essential.