Associate Director/Director, Biochemistry Lab, Analytical Sciences
- Lead Biochemistry Lab in development of immunoassay and DNA assays activities for protein therapeutics for early and late stage programs, including method development, qualification/validation, method transfer to QC, and strong collaboration with partner organizations.
- Lead the efforts in applying high-throughput workstation and analytical technology to support process development.
- Contribute to draft and review of regulatory submissions including INDs and BLAs.
- The applicant will manage a large group of scientists, he/she should be an effective communicator of ideas, project goals and results to group members.
- Strong knowledge of GMPs.
- Hands-on technical leadership of all aspects of anti-host cell protein ELISA, anti-product ELISA and qPCR assay development.
- Direct scientists in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.
- Requires a Ph.D. in biochemistry, or immunology and 8+ years of relevant experience that demonstrates an expertise in assay development and scientific accomplishments.
- Industry experiences in the development and validation of ELISA and DNA assays for CMC applications.
- Experiences with high throughput workstation and its applications.
- Record of scientific technical writing skills as demonstrated by peer-reviewed publications in science and technology journals.
- Excellent communication skills (both verbal and written) and interpersonal skills are required. Fluent in English and Chinese.
- Experience interacting with health authorities (FDA, EMA etc.) is a plus.
Primary Location: China – Shanghai
To apply please send your application to HR_Biologics@wuxiapptec.com