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Senior Scientist Bioassay and Biological Characterization

Responsibilities:

  • Lead bioassay development activities. Accountable for bioassay applications for early and late stage development programs, bioassay qualification/validation, troubleshooting, direct supervision of scientific staff, and strong collaboration with partner organizations.
  • Develop talent, inspire innovation and operational excellence and foster a continuous learning environment. 
  • Draft and review regulatory submissions including INDs and BLAs.
  • The applicant should be an effective communicator of ideas, project goals and results to cross-functional team members.  
  • Candidates should be self-motivated and organized, familiar with the relevant literature.
  • The applicant will make decisions affecting direction of project and for ensuring project timelines are met.
  • Strong knowledge of GMPs. Regulatory audit and inspection experience preferred.  
  • Hands-on technical leadership of all aspects of potency assay development.
  • Direct scientists in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.


Basic Qualifications:

  • Requires a Ph.D. in Cell Biology, Molecular Biology, or Immunology and 5-10+ years of relevant experience that demonstrates an expertise in potency assay development and scientific accomplishments.
  • Industry expert in the development and validation of biological assays for CMC applications.
  • Record of scientific technical writing skills as demonstrated by peer-reviewed publications in science and technology journals.
  • Excellent written and verbal communication skills in both English and Mandarin Chinese.
  • Experience interacting with health authorities (FDA, EMA etc.) is required.
  • Managerial experience by providing on-going mentoring, supervision, and yearly performance review and appraisal of a large group of scientists.
  • Extensive hands-on experience in potency assay development (reporter gene assays, proliferation assays, antibody effector function assays, other fluorescence and luminescence based assays, etc.).
  • Experience with immunoassay and nucleic acid assay development is a plus.


Job Function: Research & Development

Primary Location: China-Shanghai