Amber Cook Email and Phone Number

▪ Supervise and mentor a team of (3) Analytical Chemists in cGMP laboratory environment▪ Oversee method development and validation of in-house and third party test methods using HPLC, LCMS, GC, ICPMS, UV-vis, HPTLC, FTIR , and wet chemistry techniques▪ Procure and manage performance of analytical instrumentation, including IQ, OQ, PM, and repair▪ Provide technical guidance to R&D and Pilot teams to ensure new ingredients and dietary supplement formulations meet specifications using scientifically valid and appropriate test methods▪ Work closely with QC and QA to ensure our products and processes are in compliance with FDA 21 CFR (part 11, 101, 111) and maintain UL certification▪ Provide technical guidance to material review board investigations, supplier quality, new product development, material specifications, and quality compliance strategy▪ Implement internal stability testing program▪ Develop LIMS implementation plan

▪ Design and implement quality master plans to ensure company processes are in compliance with 21 CFR Part 111 and international regulations▪ Assist in FDA and UL audits serving as SME on analytical testing methods▪ Provide data and statistical justification to guide decision-making relating to batch uniformity, manufacturing and packaging processes▪ Review and approve specification sheets for raw materials and finished batches.▪ Lead cross-functional projects relating to botanical compound testing, finished batch testing, batch uniformity, process qualifications, and shelf-life testing

▪ Supervise and mentor a team of (8) Lab Analyst I and (4) Lab Analyst II within cGMP Laboratory, while management is on leave▪ Manage lab operations for QC testing, including resource and team management for microbiology, heavy metals, HPTLC, HPLC, and Misc. Chem divisions.▪ Procure laboratory equipment, consumables, reference standards, chemicals, and high purity gases▪ Monitor in-house and outsourced testing TAT, costs, and COA release metrics▪ Advise, review and approve Out-of-Specification investigations for in-house and third-party testing

▪ Develop, optimize, and validate HPLC and wet chemistry analytical methods▪ Implement method development workflow to reduce OOH testing costs▪ Preventative maintenance, troubleshooting, and repair of lab equipment and HPLC systems▪ Train and mentor QC Laboratory Analysts▪ Led laboratory facility expansion from proposal to completion while ensuring QC maintains TAT

▪ Manage supercritical fluid extraction operations▪ Review third-party test results and advise on supplier quality▪ Procure equipment, consumables, chemicals, and high-purity gases▪ New product development and pilot testing▪ Established production metrics and efficiency goals

▪ Develop LC-MS/MS quantification workflows using stable-isotope labelled hydrazide reagents and R ▪ High throughput analysis of N-linked glycans, metabolites, and peptides using FTICR, Triple Quad, and Orbitrap mass spectrometers▪ Workflow optimization using fraction factorial DOE▪ Build and manage a longitudinal biorepository of plasma and tissues for ovarian cancer research

▪ Conducted dose-response experiments of immortalized cell lines to elucidate complex cell signaling pathways using calorimetry, UV-vis, and fluorescence polarization▪ Maintenance and plate setup of primary and immortalized cell lines▪ SOP development and scientific presentations▪ Set up new laboratory facilities