Job Summary:Lead lab investigations, SME of separation, new capability development, perform method performance review and do statistical analysis before and after method validation, lead method transfer and method validation strategy discussion.Responsibilities: ·Participate in analytical method optimization, transfer/validation activities, including strategy discussion and experiments execution.·Serve as technical leader to solve technical challenges and lead laboratory investigations.·Communicate with internal/external partners or clients to ensure timely completion of method validation and smooth transfer of analytical methods.·Do statistical analysis based on historical data for method performance or for lab investigation purpose.·Draft and review technical documents such as methods, transfer/validation protocols and reports.·Update and review SOPs such as method validation and laboratory investigation based on the updated regulatory.Qualifications:·Master's degree or higher in Analytical Chemistry, Biochemistry, Molecular Biology, Biological Engineering, Statistics, or a related field.·1-2 years of experience in the bio-pharmaceutical industry for a PhD, and a minimum of 3 years for a Master's degree.·Strong communication skills in English and Chinese; 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.