Qc理化工程师

Bion Environmental Technologies Inc

On-site
3+ years antibody drug experience
Peptide mapping and purity analysis
Gmp and alcoa+ compliance knowledge
The role involves leading the detection of protein content, purity, and charge heterogeneity while ensuring data reliability under ALCOA+ principles

Job Summary

  • The role involves leading the detection of protein content, purity, and charge heterogeneity while ensuring data reliability under ALCOA+ principles.
  • Candidates must possess at least three years of experience in physicochemical analysis specifically for antibody drugs within a GMP setting.
  • The position requires managing laboratory instruments, handling deviations like OOS/OOT, and staying updated on international regulatory guidelines.

Matching Summary

The role involves leading the detection of protein content, purity, and charge heterogeneity while ensuring data reliability under ALCOA+ principles.

Skills & Requirements

Must-have

  • 3+ years antibody drug experience
  • Peptide mapping and purity analysis
  • GMP and ALCOA+ compliance knowledge
  • ICH Q2 guideline familiarity
  • Method development and validation

Nice-to-have

  • New employee coaching capability
  • Strong team collaboration skills
  • Fluent English communication
  • 5S laboratory maintenance experience

Key Requirements

  • Bachelor's degree or higher in Biochemistry or related field
  • Minimum 3 years of antibody drug physicochemical analysis experience
  • Proficiency in SEC, RP-HPLC, and CIEF techniques
  • Knowledge of Chinese Pharmacopoeia and ICH Q2 standards

Work Rights

Not specified

Tailored Resume

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