Ethan Bui Email & Phone Number

Redwood City, California, United States

• Independently lead the development and validation for analytical methods for activity, purity, content and other quality attributes of pharma enzymes, life sciences enzymes, RNA-based therapeutics and other Codexis products.• Develop reliable analytical test methods following rigorous scientific methodology and industry standard application of ICH guidelines. • Independently design and conduct physicochemical characterization, forced degradation and analytical studies on Codexis' products to support process development. • Perform data processing, evaluation and interpretation of test and experimental data, drawing conclusions based on the results. • Prepare test methods, protocols, summary reports and technical documentation.• Perform method transfer, qualification and validation in accordance with FDA and ICH guidelines.• Act as the Analytical Development SME for project teams by communicating method status, analytical data and resolution of project technical issues.• Provide technical oversight of trouble shooting and analytical investigations in cross-functional teams.• Mentor and guide junior level scientists and associates.

Cupertino, California, United States

In this role, I served as a R&D leader, managed multiple labs, and maintained analytical instruments. I conducted diverse tests on raw materials and samples, led GMP and research testing, developed test protocols, validated methods, and wrote reports. Additionally, I authored technical papers and SOPs. This tenure with Durect Corporation was marked by the following career milestones:• Facilitated the development of two successful patents.• Delivered operational oversight to three analytical laboratories and maintained regulatory compliance during audits by OSHA, EH&S, and the Fire Department.• Attained 100% of annual goals and objectives set by the company consistently.

Organic Chemistry, B-

Master Of Science - Ms, Computer And Information System