After 4 years at an amazing company, I had the opportunity to take a career break and travel through Europe with my partner for a few months before relocating to LA.

• Investigated QC discrepancies found at a partner facility while running the diagnostic assay by designing and executing experiment plans using gel electrophoresis, multiplex PCR, and next-generation sequencing (Illumina platform), resolving any potential issues for the partner lab.• Contributed to assay development by extracting gDNA from multiple sample types and preparing libraries using TA ligation and quantifying using qPCR, Qubit and TapeStation. Sequenced on miSEQ and NextSEQ instruments, analyzing bioinformatics using an in-house pipeline and JMP.• Assisted the research department with processing high priority samples as part of an external collaboration by executing the assay in a timely and accurate manner, providing crucial data for the further development of the diagnostic assay.• Collaborated with the pre-assay development team to test various conditions of DNA extraction for analysis, developing a robust analytical method and providing crucial information for an FDA IVD submission in a timely manner to meet the company’s deadlines successfully.• Supported existing clinical assays by conducting real-time, accelerated and freeze-thaw stability studies on critical reagents and drafted final and interim reports presenting data to estimate shelf life using statistical software JMP.• Trained junior and senior team members on running molecular assays which allowed the team to process development samples in-house instead of outsourcing to the lab operations team, speeding up the experimental results for various projects by several days.• Presented project progress, results, and conclusions at formal department meetings, gathering insight from the discussions to design new experiments.

• Developed reagent QC methods using Tapestation, multiplex PCR, qPCR, and NGS to improve the quality of critical reagents for T-cell and B-Cell IVDs.• Performed genomic DNA and RNA extractions using column and bead methods for use in development studies of molecular assays.• Supported GLP lab operations by manufacturing critical controls for multiple clinical diagnostic assays passing QC release, reducing PCR primer bias in the diagnostic assay.• Operated under GLP and GMP guidelines to troubleshoot failing metrics for reagent QC in operations labs, improving the QC process and resolving CAPAs.• Drafted and verified QC methods for use in the GLP lab operations, transferring the developed method and various tracking/report forms via a proper document control.• Analyzed large, complex sets of bioinformatic data from an internal pipeline using statistical data tools such as JMP to provide clear interpretations of findings and provide new ideas for further new research.

• Assessed bioavailability of novel drugs using HPLC fractionization and accelerated mass spectrometry analysis of clinical PK urine or plasma samples.• Extracted samples for HPLC analysis consisting of urine or plasma PK supplies via centrifugation and dilution with standard materials.• Assisted in developing reverse-phase HPLC methods to successfully fractionize clinical samples for Accelerated Mass Spectography analysis using Shimadzu systems.• Communicated with team members and other departments to exceed client expectations for deadlines including working on late and on weekends.• Maintained an efficient lab environment while balancing client studies by cleaning lab areas and keeping supplies stocked.

• Tested formulated drug-polymer matrices using a variety of analytical techniques such as XRPD, SEM, GC, DSC, and KF titration to check for crystallinity, residual solvents, melting temperature and residual water for QC release.• Evaluated solubility of drug-excipient dispersions by performing dissolutions tests and analyzing assay values using Agilent HPLCs via Empower3 software, narrowing down the highest performing formulation for the customer.• Conducted long-term stability studies on potential drug candidates to estimate shelf life and optimal storage conditions by analyzing assay and impurities via HPLC including the analysis of a cGMP drug product using a validated method.• Developed SOPs for analytical techniques such as XRPD and DSC to ensure quality and repeatability of analysis in the Early Development team.• Collaborated with team members to reach all billing milestones ahead of time including reports and presentation slides.• Trained interns on laboratory practices such as solution preparation and analytical techniques following SOP requirements.