Qc理化高级工程师

Bion Environmental Technologies Inc

On-site
3+ years antibody drug experience
Empower software proficiency
Peptide mapping and purity analysis
The role involves leading the optimization, transfer, and validation of physicochemical analysis methods for protein drugs in a GMP setting

Job Summary

  • The role involves leading the optimization, transfer, and validation of physicochemical analysis methods for protein drugs in a GMP setting.
  • Candidates must ensure strict adherence to ALCOA+ data reliability standards while managing deviations and out-of-specification results.
  • The position requires expertise in specific analytical techniques such as peptide mapping, SEC purity analysis, and isoelectric point determination.

Matching Summary

The role involves leading the optimization, transfer, and validation of physicochemical analysis methods for protein drugs in a GMP setting.

Skills & Requirements

Must-have

  • 3+ years antibody drug experience
  • Empower software proficiency
  • Peptide mapping and purity analysis
  • GMP and ICH Q2 regulatory knowledge
  • ALCOA+ data integrity principles

Nice-to-have

  • Mentoring junior engineers
  • Strong English communication skills
  • 5S laboratory maintenance
  • Cross-functional team collaboration

Key Requirements

  • Minimum 3 years experience in antibody drug physicochemical analysis
  • Proficiency with Empower chromatography data system
  • Knowledge of Chinese Pharmacopoeia and GMP regulations
  • Ability to guide and mentor other engineers

Work Rights

Not specified

Tailored Resume

Cover Letter