Shawn Burton

About Shawn Burton

Experienced Project Manager and Bioanalytical Leader with over 10 years in the pharmaceutical sector, specializing in the successful execution of bioanalytical strategies for drug development. My background includes comprehensive oversight of bioanalytical operations for both pre-clinical and clinical trials, from assay development and validation (particularly using LC/MS) to sample analysis and reporting. At Aliri Bio, as a Principal Analytical Investigator, I lead a team of scientists, ensuring adherence to stringent regulatory standards (GLP/GCP), optimizing workflows, and effectively managing stakeholder relationships. I am adept at leveraging my strong analytical, communication, and leadership skills to deliver high-quality, timely results within budget. My core competencies encompass bioanalytical method development and validation, LC/MS operations, pharmacokinetic and toxicological data management, quality systems, regulatory compliance, project planning, risk management, and cross-functional team leadership. I am now seeking to apply my expertise in a dedicated Project Management role within a forward-thinking bioanalytical organization.

Experience

1. Principal Analytical Investigator Iii

   Aliri Bioanalysis

   Apr 2022 — Present

   Chart successful course of directing bioanalytical operations for both pre-clinical and clinical studies to ensure the seamless execution of bioanalytical assays, sample analysis, and data interpretation.• Direct and mentor a team of scientists in the development and optimization of bioanalytical assays for innovative small molecules, consistently meeting or surpassing industry best practices, method validation requirements, and stringent regulatory guidelines.• Align objectives and bridge-communications with cross-functional teams to gather and prepare comprehensive data packages essential for the submission of new drug applications to the U.S. Food and Drug Administration (FDA). • Generate comprehensive reports and communicate findings to senior management, regulatory authorities, and auditors, ensuring transparency and compliance throughout the investigative process. • Deliver presentations on various aspects of directing the analysis of bioanalytical studies, which can range from regulatory requirements for conducting a study to developing an extraction method utilized for analyzing GLP/GCP studies.• Share insights to enhance Standard Operating Procedures (SOPs) to ensure alignment with changing regulations.KEY ACHIEVEMENTS• Reduce backlog by 50% by implementing workflow enhancements that significantly boost productivity.

Education

• Brigham Young University - Idaho

  Bachelor's Degree, Chemistry

  2006 — 2012

• University of Utah

  Master's Degree, Chemistry

  2013 — 2015

Skills

• Hplc
• Ftir
• Nmr Spectroscopy
• Circular Dichroism
• Sds-Page
• Microsoft Excel
• Microsoft Word
• Powerpoint
• Uplc
• Uv/Vis
• Chemdraw
• Pymol
• Spanish