Job Summary:
Lead lab investigations, SME of separation, biochemical and cell-based assays, 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:
61Participate in analytical method optimization, transfer/validation activities, including strategy discussion and experiments execution.
61Serve as technical leader to solve technical challenges and lead laboratory investigations.
61Communicate with internal/external partners or clients to ensure timely completion of method validation and smooth transfer of analytical methods.
61Do statistical analysis based on historical data for method performance or for lab investigation purpose.
61Draft and review technical documents such as methods, transfer/validation protocols and reports.
61Update and review SOPs such as method validation and laboratory investigation based on the updated regulatory.

Qualifications:
61Master's degree or higher in Analytical Chemistry, Biochemistry, Molecular Biology, Biological Engineering, Statistics, or a related field.
61Minimum 5 years of relevant work experience in bio-pharmaceutical industry for Master Degree, and a minimum of 1-2 years for a Ph.D degree.
61Strong communication skills in English and Chinese; Fluent in speaking, writing, and reading in both languages.
61Critical thinking, scientific reasoning, and problem-solving skills.
61Familiar with statistical analysis.
61Proficient in technical writing in English and familiar with statistical analysis models and suitable ranges.