理化分析研究员

Key Responsibilities

• Develop, validate, and troubleshoot CE/CIEF methods for the analysis of therapeutic proteins, antibodies, or related biomolecules.
• Collaborate with cross-functional teams (R&D, QC, QA) to support method transfers, investigations, and process improvements.
• Ensure compliance with regulatory guidelines (e.g., ICH, USP, FDA) and internal SOPs.
• Perform routine and non-routine testing of samples using CE/CIEF techniques.
• Operate and maintain CE/CIEF instrumentation (e.g., SCIEX PA 800 Plus, ProteinSimple iCE3/Maurice) and associated software (e.g., Empower).
• Document experimental data, analyze results, and prepare technical reports in compliance with internal SOP.
• Stay updated on advancements in CE/CIEF technologies and industry best practices.

Qualifications

• Education: Bachelor’s degree in Analytical Chemistry, Biochemistry, Biotechnology, or a related field.
• Experience (expected but not must): 2 years of hands-on experience with CE/CIEF methodologies in a biopharmaceutical, CRO, or academic setting
• Technical Skills (expected but not must)

Proficiency in CE/CIEF instrumentation and data analysis.

Familiarity with protein characterization techniques (e.g., SDS-PAGE, HPLC, mass spectrometry) is a plus.

• Soft Skills: Strong problem-solving abilities, attention to detail, and excellent communication skills (in both Chinese and English). Ability to work independently and in a team environment.