Responsibilities and Duties:
−To perform method development and testing related to the biosafety ofbiological products, including virus culture, cell bank establishment,virus titer measurement, testing for endogenous/adventitious viralcontamination in cells, virus clearance validation, etc.
−To know the advanced biotesting methods; To perform biological testsindependently and accurately strictly following the standards andprocedure.
−To solve technical problems occurred in the work, and report to thesupervisor if necessary.
−To assist in the inspection from regulatory authorities and clients;
−To investigate client complaints timely and independently; to conductinvestigations including CAPA, OOS and deviation in accordance with thequality requirements of the GMP system, and report back to superiors andQA when necessary.
Qualifications:
−Major: Bioengineering, Molecular Biology, or Virology; at leastbachelor degree;
−English: at least CET6 level;
−At least four years’ experience on bio testing;
−Be able to perform at least 2-3 of the following tests independently:
Virus cultivation, virus infection on cells, hemadsorption test, virustiter measurement, virus clearance validation, real time PCR, ELISA,Western blot, cell operation (resuscitation, culture and subculture),SDS-PAGE, etc;
−Familiar with the essentials of 5S management operation;
−Familiar with GMP/GLP quality management system;
−Familiar with office software;
−Strong communication skills, carefulness ability to work under pressure;
−Good sense of teamwork;
Key factors:
−Familiar with Biological assays, especially virus cultivation,purification, detection, and clearance validation;
−Strong learning ability, able to search and review literature both inChinese and English;
−Experience on method development, able to identify and report problemsarising in daily work;
−Strong sense of teamwork and independent thinking;
−Fluent English.