Job Summary

Assist in lab investigations, perform method performance and do statistical analysis, as well as method transfer and method qualification/validation.

Responsibilities

• · Establish, implement, and maintain analytical methodologies, Standard Operating Procedures (SOPs), and Protocol/Report Templates in alignment with regulatory requirements and internal quality standards.
• · Lead the lifecycle management of analytical methods, ensuring timely updates and continuous improvements based on scientific data, performance metrics, and industry best practices
• · Monitor and periodically review all laboratory events, including Out-of-Specification (OOS), Out-of-Trend (OOT), equipment failures, and procedural deviations.
• · Communicate with internal/external partners or clients to ensure timely completion of method qualification/validation and smooth transfer of analytical methods.
• · Do statistical analysis based on historical data for method performance or for lab investigation purpose.

Qualifications

• · Bachelor's degree or higher in Analytical Chemistry, Biochemistry, Microbiology, Biology, Molecular Biology, Biological Engineering, Statistics, or a related field.
• · Strong communication skills in English and Chinese (as this role requires frequent internal collaboration with Chinese-speaking colleagues in HQ); fluent in speaking, writing, and reading in both languages. Critical thinking, scientific reasoning, and problem-solving skills. Familiar with statistical analysis.
• · Proficient in technical writing in English and familiar with statistical analysis models and suitable ranges.