Senior Scientist Bioassay and Biological Characterization
- 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.
- 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