Qc生化高级工程师

Bion Environmental Technologies Inc

On-site
Antibody drug biochemical analysis experience
Protein a and hcp residue detection methods
Gmp environment compliance and alcoa+ principles
The role involves leading biochemical analysis methods including cell activity, protein content, and various residue detections for antibody drugs

Job Summary

  • The role involves leading biochemical analysis methods including cell activity, protein content, and various residue detections for antibody drugs.
  • Candidates must ensure strict adherence to data reliability principles (ALCOA+) and GMP regulations while managing lab documentation.
  • The position requires independent execution of analytical work in a GMP environment with the ability to guide junior engineers.

Matching Summary

The role involves leading biochemical analysis methods including cell activity, protein content, and various residue detections for antibody drugs.

Skills & Requirements

Must-have

  • Antibody drug biochemical analysis experience
  • Protein A and HCP residue detection methods
  • GMP environment compliance and ALCOA+ principles
  • Method optimization and validation execution
  • Deviation and OOS investigation participation

Nice-to-have

  • Strong English communication skills
  • Team leadership and mentoring capabilities
  • Regulatory guideline difference analysis
  • 5S laboratory maintenance proficiency

Key Requirements

  • 3+ years antibody drug biochemical analysis experience
  • Proficiency in at least 3 specific assay principles
  • Knowledge of Chinese Pharmacopoeia and ICH Q2 guidelines
  • Fluent English reading, speaking, and writing skills

Work Rights

Not specified

Tailored Resume

Cover Letter