Discovery

Development

Testing

Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Antibody Drug Conjugates

Technologies & Platforms

Responsibilities

  • 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.
  • Lead the efforts in applying high-throughput workstation and technology.
  • 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.

Basic Qualifications:

  • 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.

 

Primary Location: China – Shanghai

To apply please send your application to HR_Biologics@wuxiapptec.com

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