• Collaborate internally and externally to manage a team focused on method monitoring and method lifecycle management of molecular, cell-based, and immunological-based test methods• Lead the implementation of a method monitoring program focused on analytical method performance, including assessment of analytical method system suitability requirements • Define the requirements for statistical data analysis for method performance monitoring and reporting in accordance with cGMP/ICH/FDA/EU regulations• Lead the identification of methods requiring remediation or additional robustness studies based on trends or other method-based investigations• Support analysis of process monitoring trends in cross-functional matrixed environment.• Lead cGMP operations, including technical review of method change controls, deviations, OOS, OOT, and other manufacturing and laboratory investigations• Lead the review and revision of internal SOPs/policies to align with industry standards related to analytical method monitoring, assay trending, and critical reagent lifecycle

B Company, 325th MI BattalionTrained on all-source intelligence analysis, focusing on expeditionary military operations. Responsible for producing multi-source intelligence products to inform planned and ongoing operations.• Identified information gaps and potential threats by evaluating relevance and accuracy of gathered information using various analytical methodologies and intelligence database systems.• Disseminated warning and threat analysis and briefed executive and senior management on actionable intelligence contingencies.• Updated extensive intelligence databases, systems, and mechanisms for sharing relevant intelligence information to support ongoing and planned projects.• Led technical development and strategic implementation of various new intelligence initiatives.• Produced complex multi-source intelligence products derived from intelligence data collection, analysis, evaluation, and interpretation.• Mentored junior analysts and acted as a team leader, managing personnel productivity and resources.

Responsible for designing and implementing root cause analysis investigations and troubleshooting, test method development and optimization, designing validation studies and execution of validation studies for unique and compendial assays and test methods compliant with United States Pharmacopeia (USP) and European Pharmacopeia (EP) regulations for drug products used in Food and Drug Administration (FDA) approved human clinical trials, continuous trending and statistical data analysis, authoring investigation and qualification reports, authoring of QC programs and standard operating protocols, training new QC personnel, subject matter expert on proprietary molecular biological and microbiological assays, and subject matter expert on anaerobic microbiology and anaerobic environmental systems. • Provided statistical and data analysis support for continuous trending programs and root cause analysis investigations.• Developed qualification studies for reference material critical to assay control and drug product release and compliant with USP and EP regulations. • Designed and executed two major root cause analysis investigations regarding critical drug product release assays, enabling human clinical trials to continue as scheduled. • Designed and executed two test method validations compliant with USP and EP regulations.• Designed and executed four test method technology transfers compliant with USP and EP regulations.• Developed QC department new employee training program.• Trained QC Senior Director and QC Associate Director on proprietary test methods and assays as a subject matter expert.• Trained three new junior analysts on key job performance tasks and responsibilities.• Generated Certificate of Analysis (CoA) documentation for multiple lots of drug products used in FDA approved Phase 1, Phase 2, and Phase 3 human clinical trials.• Performed release testing of drug products used in FDA approved Phase 1, Phase 2, and Phase 3 human clinical trials.

Key analyst in developing and building out the QC department. Responsible for development and improvement of proprietary test methods, aiding in development of compliance programs and authoring of quality control programs and standard operating protocols, routine testing on drug product used for clinical trials, training new QC personnel, subject matter expert on molecular biological and microbiological assays, and subject matter expert on anaerobic microbiology and anaerobic environmental systems. • Provided statistical and data analysis support for continuous trending programs and root cause analysis investigations.• Developed qualification studies for reference material critical to assay control and drug product release and compliant with USP and EP regulations. • Developed department new employee training program.• Trained QC Manager on proprietary test methods and assays as a subject matter expert.• Trained four new analysts on key job performance tasks and responsibilities.• Performed release testing of drug products used in FDA approved Phase 1 and Phase 2 human clinical trials.

-Assist in assay development, validation, and troubleshooting.-Perform characterization and stability assays on various samples.-Generate and revise SOPs.

Laboratory technician in the HDL Laboratory. Responsible for performing proprietary testing on diagnostic samples, maintaining Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) laboratory regulations and standards, maintaining HIPAA standards throughout the testing process, and ensuring diagnostic results are accurate. • Performed the HDL Map test on patient samples through 2-dimensional electrophoresis and Western Blotting, ensuring accuracy of test results.• Utilized and maintained radioactive material I125 needed for HDL Map testing. • Manufactured 3-35% polyacrylamide gels essential for HDL Map test process.• Participated in two CLIA and CAP annual audits.

-Designed and conducted independent research on the transfer of multi-drug resistance between Aeromonas salmonicida and Vibrio cholerae strains (O395, O395-N1, CG842, C6706, BAA-2163) in liquid environments in the presence and absence of chitin.-Wrote and submitted a senior thesis on above mentioned research.

-Conducted research on conjugation frequencies between Aeromonas salmonicida and Vibrio cholerae strains (O395, C6706, BAA-2163, MQ-1795) in both solid biofilm environments and liquid environments. -Created a mutagenesis library of Janthinobacterium lividum and Janthinobacterium environmental isolates for further research.

School of Chemistry & Biochemistry, Parker H. Petit Institute for Bioengineering & Bioscience, Donald Doyle Lab-Assisted in research on the nuclear receptor estrogen receptor (rat) by testing activation using synthetic ligands.-Created a mutagensis library of estrogen receptor (rat) strains in E. coli for further research.

School of Chemistry & Biochemistry, Parker H. Petit Institute for Bioengineering & Bioscience, Donald Doyle Lab-Worked with Dr. Bahareh Azizi and PhD candidates in the lab and assist them in their research.-Ran gels, performed PCR reactions, transcript and end label RNA, passaged mammalian cells, and carried out other procedures concerning yeast studies.-Helped with laboratory organization efforts