Protein Analytical Service Assistant or Associate Director_Biologics
• Lead immunoassay and DNA assay development activities for development of protein therapeutics for early and late stage programs, including method development, qualification/validation, troubleshooting, direct supervision of scientific staff, and strong collaboration with partner organizations.
• Contribute to draft and review of 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.
• 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 5-10+ years of relevant experience that demonstrates an expertise in assay development and scientific accomplishments.
• Industry expert 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.
• Managerial experience by providing on-going mentoring, supervision, and yearly performance review and appraisal of a large group of scientists.
Any applications, pls contact: firstname.lastname@example.org; email@example.com