Charles Kerr

Quality Engineering Principal Feb2024 – April 2025 • Translated stakeholder requirements into script-based solutions within organization's technical and fiscal constraints: • Designed dashboards for change controls, CAPAs and Deviations vs due dates, providing cross-functional visibility to deadlines and reducing past-due quality record closure. Data processing done in R with a PowerBI dashboard output. • Designed training compliance dashboards to visualize individual compliance with curricula and lapsed training. Prepared in R and RMarkdown to provide individual reports in common document formats (.html, .docx, .pdf). • Staged DMS migration data & documents using R and other tools to reduce manual handling errors and improve efficiency. • Provided Quality oversight of CAPAs, deviations, change controls, maintenance/calibration records and work orders. • Provided Quality oversight on software-related issues (IOQ, upgrades, deviations, bugs, etc.) for OS and applications. Manager Quality Unit Sep2020 – Feb2024 • Designed, planned, and executed document and data preparation and staging for migration between electronic document management systems, including R code and other tools to reduce manual handling errors and improve efficiency. • Collaborated cross-functionally to qualify and implement GxP computerized systems: MODA-EM (initial implementation), QAD ERP system (expansion). • Served as Quality / Validation lead for first CSA project at the site (QAD expansion), leading computer system risk assessments and test script designs to CSA approach, resulting in completing the qualification with minimal discrepancies. • Authored, reviewed and approved standard operating procedures and validation documents. Leveraged QGIS Atlas Builder functions to render facility maps for EM sampling SOP. • Authored, reviewed and approved GxP software validation documentation (URS, FRS, RTM, protocol & acceptance report).

• Built & maintained company's first rapid Environmental Monitoring & Utility Testing data reporting, resulting in improved audit performance (client and agency). • Built & maintained company's quality & operations KPI dashboards for the allergenic & CMO business units, resulting in substantial time savings compared to other company sites. • Built in-house reporting tools for rapid, automated daily reporting to stakeholders in EM, operations, and Quality. • Created map files needed to add spatial context to facility data reported to EM, operations and Quality. (QGIS, JMP)

• Managed QC responsibilities for client projects, including method transfer / validation, cGMP documentation, and annual reporting. • Collaborated with other functions as the QC representative for multi-million dollar contract client for 6 years, onboarding for 10 different clinical trial products & supporting launch of 1 client commercial product. Included method transfer and validation, equipment qualification, supporting testing (API, in-process and final container), laboratory investigation, and testing data compilation for annual product reviews. • Performing laboratory investigations and responding to FDA audit findings. • Planned & executed investigation into delamination-resistant glass vials, resulting in identification of 2 possible suppliers. • Train analysts on testing, equipment, project management and software (Excel, SAP, JMP, QGIS, Acrobat).

-Responsible for identifying and implementing process improvements and troubleshooting process development -Supplied pre-production lots of materials under cGMP -Preparing process and test method documentation for FDA clearance -Characterization and validation of test methods and manufacturing processes -Trained synthesis personnel and managed synthesis facility -Managed hazardous waste handling and shipment -Developed multi step synthesis of two phosphoramidites -Developed 12 step synthesis of molecular wire compound intended for QC -Improved yield and reduced process toxicity of a controlled pore glass reagent -Synthesized 5-alkynyldeoxyuridines, 3-aminodeoxyguanosines, carbodiimides, mono- and di- substituted ferrocenes, mono-halo-ferrocenes, water soluble ferrocene labeled polymer

One year appointment at Washington State University followed by two years at Georgia State. -Trained chemists and maintained synthesis facility -Presented research findings in refereed journals and at conferences -Synthesized novel nucleoside analogs resulting in 4 publications

-Research on novel iron-mediated reactions and compounds -Characterized the rates and fidelity of reverse transcription of modified oligonucleotides -Synthesizes allenes, vinylallenes, diallenes, butenolides, alkynes, universal bases, triphosphates, nucleoside analogs, & pyrimidines

-Trained lab personnel -Research and development of proprietary microscale mineralogical assay -Maintained field lab

-Responsible for executing and documenting results of chemical and physical tests performed on highway construction materials and motor oil -Used ASHTO and ASTM protocols

Dissertation: Allenic Iron Carbonyls, Nucleoside Analogs, and Enzymology of Oligonucleotide Preparation Using Nucleoside Analogs -Synthesized, purified and characterized small organic and organometallic molecules -Developed understanding of traditional organic and organometallic synthesis -Investigated relative rates of reverse transcription of modified oligonucleotides

Developed understanding of major chemistry disciplines