Discovery

Development

Testing

Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Antibody Drug Conjugates

Technologies & Platforms

Responsibilities

  • Lead a group of scientists to develop HPLC/UPLC, CE, MS methods 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 product characterization efforts by biochemical and biophysical techniques for proteins.
  • Develop talent, inspire innovation and operational excellence and foster a continuous learning environment.
  • Draft and review of relevant CMC sections for 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.

Basic Qualifications:

  • Requires a Ph.D. in analytical chemistry, biochemistry and 8+ years of relevant experience that demonstrates an expertise in assay development and scientific accomplishments.
  • Hands-on experience in the development and validation of HPLC, CE, and MS methods for CMC applications.
  • Experience with biochemical and biophysical characterization of protein therapeutics.
  • 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 (CFDA, FDA, EMA etc.) is preferred.
  • 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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