职位描述：
job summary:
the qualified candidates will join the bioanalytical department to enable the optimization, development, validation and application of analytical methods to characterize the in vitro and/or in vivo activities, the impurities/residuals of drug substances and drug products.
job responsibilities:
· optimize or develop analytical methods for pre-clinical and clinical stage biotherapeutics characterizations.
· modify or write standard operation procedure (sop) to characterize the in vitro and/or in vivo activities of ds (drug substances) and dp (drug products), to test and quantify the process impurities/residuals in biopharmaceutical products.
· develop analytical methods for intermediates as part of pat (process analytical technology).
· involved in technology transfer from other companies.
· perform all experiments under applicable safety and regulatory compliances.
· generate high quality results in support of analytical testing of growing drug pipeline.
· document data/results according to applicable compliances, such as glp and gmp.
· effective communication of data/results through written documentation and oral presentations.
· accountable for completing the assigned tasks and communicate results in a timely manner.
· perform other duties as assigned.
basic requirements:
· a master degree in biological science, preferably in cellular, molecular biology or immunology, with 1-3 years of experience within a biopharmaceutical industry analytical laboratory.
· strong experience with cell culture and cell-based assays and elisa-based assays.
· experience with quantitative pcr and molecular biology techniques.
· ability to work independently，with minimal supervision，and to manage multiple projects at one time.
· good written and oral communication skills in english.
· eager and quick to learn, self-driven and motivated.