Yang Li

• Serve as Study Director or Principal Investigator under GLP requirements; author study plans and reports, and lead method development, validation, and sample analysis activities.
• Investigate OOS results, author deviations, and respond to QA audit findings, ensuring compliance and study integrity.
• Communicate with clients through email and video conferences, providing study updates and technical presentations.
• Collaborate with other Study Directors and cross-functional departments to optimize laboratory processes and procedures, enhancing study turnaround time.
• Manage 5+ complex projects simultaneously, meeting all relevant milestones and client deadlines.
• Perform advanced troubleshooting and lead initiatives to resolve challenging scientific problems with assays and instrumentation.
• Supervise Analysts and Senior Analysts in executing assigned studies, improving workflow efficiency and data quality.
• Train and mentor newly hired scientists to rapidly adapt to the laboratory, integrate with the team, and carry out assigned tasks.
• Stay up to date with new technologies and apply them to improve lab efficiency, quality, and support new business opportunities.

In addition to performing all analyst responsibilities:

• Assisted scientists in preparing validation plans, technical reports, and SOPs, ensuring all documentation met regulatory standards and study protocols.
• Monitored and interpreted test results, identified irregularities, investigated deviations, and contributed to root cause analysis and CAPA implementation.
• Provided technical oversight on assigned studies, ensuring timely completion in compliance with GLP regulations.
• Collaborated with internal departments to support study execution and cross-functional communication.
• Trained and mentored newly hired analysts to rapidly develop laboratory skills and maintain quality standards.

• Worked in a GLP-compliant environment, performing bio-analytical assays in method development/transfer, validation, and sample analysis for dose formulation, PK, and biomarker studies using methods such as UV, BCA, and ELISA.
• Assays consistently completed on schedule with high success rates; frequently assigned to critical experiments such as long-term stability tests.
• Reviewed and interpreted raw data according to GLP standards, ensured accuracy, completeness, and proper documentation of test results.
• Assisted in investigations of OOS and deviations, contributing to root cause analysis and CAPA implementation.
• Troubleshot technical issues with instruments, assays, or analytical methods, identified root causes, and implemented effective solutions to maintain reliable laboratory operations.
• Prepared SOPs in compliance with GLP and study protocols.
• Conducted routine laboratory operations, including sample reception, reagent preparation, and instrument calibration & maintenance, ensuring compliance with regulatory and internal quality standards.
• Collaborated with internal teams and scientists, ensuring clear communication of results and observations.