BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
Education/ Professional Qualification
Bachelor or above degree in Pharmaceutical, Chemical, biological or related field.
Familiar with the regulatory requirement of NMPA cGMP、EU cGMP、PIC/S and FDA cGMP；
熟悉NMPA cGMP、EU cGMP、PIC/S 及FDA cGMP的要求；
Familiar with MAB Downstream Purification techniques and scale up of process, including Chromatography, Viral inactivation, Viral filtration, UF/DF etc；
Strongly address, investigate and solve ability.
At least 5 years BIO manufacturing experiences and at least 2 years supervisory/managerial roles.
Language, Computer Literacy, Office Software, etc.
Good English and computer skill.
Proactive and dedicated with a strong sense of responsibility and integrity;
Competent in organization and coordination, team leadership, analytical skills and problem solving;
Good communication skills.
Lead and participate in the validation activities include URS/FAT/SAT/IQ/OQ/PQ of DS downstream Equipment；
Lead and participate in GMP documents preparing, revising, and management of DS downstream department ；
Lead and participate in validation jobs of DS downstream department；
Make production Plan according to the supply chainplan, include documents preparation, material preparation, buffer preparation, process operation, people management, and so on；
To be responsible for the training, instruction and management of DS downstream, coordinate effective communication and cooperation among units relating to production and to ensure the successful completion of production;
Any other assignment as is determined by supervisor.
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