Discovery

Development

Testing

Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Antibody Drug Conjugates

Technologies & Platforms

Responsibilities

  • 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.

 

Basic Qualifications:

  • 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

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