Principal Scientist/senior Principal Scientist, Bioanalysis, Psts China

Johnson & Johnson Innovative Medicine (JJIM)

Shanghai, China
Bioanalytical scientific expertise
Pk and immunogenicity analysis
Glp/gclp compliance
This position is expected to provide bioanalytical scientific and operational expertise to clinical study teams to implement and execute all bioanalytical methods to evaluate PK and immunogenicity analysis

Job Summary

  • This position is expected to provide bioanalytical scientific and operational expertise to clinical study teams to implement and execute all bioanalytical methods to evaluate PK and immunogenicity analysis.
  • The position serves as a single point of contact between clinical development teams in China/USA and CROs to conduct assay transfer/validation from internal labs.
  • Ensure BA related submission dossier ready for NMPA CTA/NDA application and contribute to the preparation of regulatory submissions.

Matching Summary

This position is expected to provide bioanalytical scientific and operational expertise to clinical study teams to implement and execute all bioanalytical methods to evaluate PK and immunogenicity analysis.

Skills & Requirements

Must-have

  • bioanalytical scientific expertise
  • PK and immunogenicity analysis
  • GLP/GCLP compliance
  • bioanalytical strategy development
  • CRO oversight and management

Nice-to-have

  • innovative mindset
  • open and honest collaborations
  • continuous improvement culture

Key Requirements

  • Master or above degree (PhD preferred)
  • > 8 years working experience
  • experience with clinical trials preferred
  • expertise in ligand binding assays
  • understanding of GLP/GCLP and regulatory guidance

Work Rights

Not specified

Tailored Resume

Cover Letter