[gc녹십자][경력] R&d 바이오의약품 품질 분석 담당자 (본사)

GC녹십자

Yongin, South Korea
On-site
Qbd based method development
Statistical data analysis
Bio-pharmaceutical quality analysis
Perform method development and validation for bio-pharmaceutical quality evaluation using QbD (Quality by Design) principles

Job Summary

  • Perform method development and validation for bio-pharmaceutical quality evaluation using QbD (Quality by Design) principles.
  • Conduct data analysis using statistical methods and develop/optimize methods based on AQbD.
  • Responsible for authoring and reviewing development documents and regulatory submission materials, and responding to regulatory agencies.

Matching Summary

Perform method development and validation for bio-pharmaceutical quality evaluation using QbD (Quality by Design) principles.

Skills & Requirements

Must-have

  • QbD based method development
  • statistical data analysis
  • bio-pharmaceutical quality analysis
  • method development and validation
  • technical transfer

Nice-to-have

  • global regulatory response experience
  • cell based assay experience
  • proficiency in English language

Key Requirements

  • Master's degree or higher
  • 3+ years of relevant experience
  • Major in Biotechnology, Biology, Immunology, or Virology
  • Understanding and application of statistical experimental methods (QbD, DoE)

Work Rights

Not specified

Tailored Resume

Cover Letter