杭州招聘

Biologics are emerging as first line treatment for select cancer and autoimmune diseases in recent decade. 7 out of 10 bestselling drugs ranked on revenue in 2017 is biologics, compared to 0 out of 10 in 2003 and 3 out of 10 in 2012.   Biological assay (bioassay) is in vitro reduction of seemingly complicated drug clinical responses to simple clear concepts at cellular or molecular levels, hence allowing strategic clarity of patient safety and effectiveness. It provides a great opportunity to develop to your critical thinking for the better life of our patients.   WuXi Biologics is the largest biologics developer and manufacturer in China with over 50% of market occupation. It is a great company for your to learn and growth, a good one to work with.   

 Responsibilities:  

• Innovation skills and leadership in development of cell-based assays and immunoassays in support of therapeutic antibody or other biotech product portfolio.
• Ensure compliance to regulatory requirement, including instrument maintenance, personnel training, document drafting, review and archiving.
• Gradually manage a team of junior scientists to conduct bioassay development, qualification / validation and sample testing for lot release, in-process, Stability and R&D samples under a non-GMP or GMP environment until established as part of a clinical control system.
• Transfer, training and trouble-shooting of Cell-based Assays to collaborating QC labs
• Represent the department in CMC team for selected projects.
• Draft and review regulatory submissions including INDs and BLAs. Interaction with regulatory agencies such as US FDA and China NMPA on a regular basis.

Basic Qualifications:

• PhD in Biochemistry / Biotechnology, Cell Biology, Immunology or related field.
• 0-3 years of industrial experience in functional biochemical, cell-based assay, and potency assay.
• Strong working knowledge of regulatory requirement.  Experience with the use of electronic lab notebooks.
• Strong technical innovation and trouble-shooting skills in bioassay or immunoassay development, validation, and performance.
• In-depth knowledge with ELISA, flow cytometry, cell signal transduction, immune regulation and mammalian cell culture.
• Excellent spoken and written communication skills in English is a must.
• Experience with regulatory filings preferred.

Job Function: R&D, Quality

Primary Location: China – Shanghai

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