QC生化高级工程师

Responsible for conducting biochemistry tests, optimizing analytical methods, and managing the biochemistry group and QC-related files. Ensures data reliability and conforms to ALCOA+ regulations. Supports instrument installation, debugging, and maintenance, and tracks regulatory requirements.

Requirements

• At least 3 years of experience in biochemistry analysis of antibody drugs
• Master at least 3 experimental principles and methods: enzyme activity, cell bioactivity, protein content, HCP retention, Protein A retention, and DNA retention
• Understand the current version of the Chinese Pharmacopoeia and GMP, and familiar with ICH Q2
• Proficient in English reading, speaking, and writing
• Good professional ethics and teamwork skills
• Proficient in using MS-Word, MS-Excel, MS-Outlook, and other office software