- Lead a large group of scientific staff developing cell-based/ELISA based potency bioassay for early and late phase biologics CMC development, bioassay qualification/validation, troubleshooting, direct supervision of scientific staff, and strong collaboration with partner organizations.
- Draft and review regulatory submissions including INDs and BLAs.
- Develop young staff, inspire innovation and operational excellence and foster a continuous learning environment.
- 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.
- Experiences in cGMP and regulatory audit are preferred.
- Direct scientists in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.
WuXi Biologics
Offering End-to-End Solutions
职位信息
职位信息
Director, Bioassay Analytical Science
Director, Bioassay Analytical Science
中国 shanghai
工作职责：
任职能力：
- Requires a Ph.D. in Cell Biology, Molecular Biology, or Immunology and 8+ years of relevant experiences that demonstrates an expertise in potency assay development and scientific accomplishments.
- Industrial biologics development experiences 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 communication skills and interpersonal skills are required. Fluent in English and Chinese.
- Experience interacting with health authorities (FDA, EMA, NMPA, 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.).