1. Analytical Associate Scientist, Biologics (1-2 people)
The qualified candidates will join the Technology Transfer 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.
· 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.
· 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.