Katherine Church-Nguyen
San Diego,CA
Summary
Highly ambitious, licensed Clinical Laboratory Scientist (CLS) Supervisor with 14 years of Molecular Biology experience in a clinical setting and several years of laboratory leadership. Dedicated to providing exceptional patient testing, demonstrating a strong commitment to quality and accuracy. A natural leader with outstanding relationship-building and communication skills, known for fostering a collaborative work environment.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Supervisor, Clinical Laboratory Scientist
Biotheranostics, A Hologic Company
San Diego, California
11.2021 - Current
- Oversee day-to-day operations of a team of 10 CLS, ensuring maintenance of key performance indicators (KPIs) for the laboratory.
- Established clear goals to foster collaborative working among employees, enhancing team efficiency and productivity.
- Performed and documented preventive maintenance and quality control practices, identifying and implementing the best corrective actions to remediate issues.
- Established and maintained Clinical Genetic Molecular Biologist (CGMBS) Training Program to provide growth opportunities for staff, enabling them to obtain the CGMBS California license through California Laboratory Field Services.
- Contributed to laboratory team efforts by participating in strategic planning and continuous improvement initiatives to enhance overall laboratory performance. Individual competency assessment, towards maintaining efficiency in the environment.
Lead, Clinical Laboratory Scientist
Biotheranostics, A Hologic Company
San Diego, CA
09.2020 - 10.2021
- Responsible for leading a team of CLS in the Clinical Laboratory in accordance with Biotheranostics' SOPs and CLIA/CAP standards.
- Successfully trained multiple CLS to perform the Breast Cancer Index (BCI) assay in accordance with Biotheranostics' SOPs and CLIA/CAP standards.
- Responsible for providing data-driven insights to executive leadership that influence decision-making on quality control measurements and patient samples.
- Responsible for verifying in-phase reagent qualification documentation for accuracy by assessing statistics, sample concordance, and critical values.
- Created and managed CLS schedule to delegate work and meet project and production goals.
Clinical Laboratory Scientist
Biotheranostics, A Hologic Company
San Diego, CA
01.2018 - 08.2020
- Responsible for testing clinical tumor samples for levels of RNA expression in established biomarkers to determine predictive therapy for breast and metastatic cancers in accordance with Biotheranostics' SOPs and CLIA/CAP standards.
- Extracted RNA from FFPE tumor slides and performed reverse transcriptase and real-time PCR for clinical testing.
- Operated and maintained ABI 7900s and Quantstudio Dx instruments for clinical testing.
- Performed real-time PCR data analysis using ABI Software.
- Established and coordinated the implementation of Professional Acknowledgment for Continuing Education (P.A.C.E.) program.
- Led and established an efficient inventory management system that improved laboratory
uptime and organization. - Prepared validation reports, drafts, SOP's and training documents for CLIA and CAP inspections.
Clinical Laboratory Scientist
GenomeDx Biosciences
San Diego, CA
07.2016 - 01.2020
- Responsible for testing clinical samples for levels of RNA expression in various Biomarkers to determine the aggressiveness of cancers in accordance with GenomeDx SOPs and CLIA/CAP standards.
- Extracted and isolated RNA from FFPE prostate tissue using the Qiagen Qiacube as well as manual extraction methods.
- Performed reverse transcriptase PCR for cDNA synthesis on patient samples.
- Operated and maintained Affymetrix microarray platforms for microarray analysis.
- Prepared reagents and controls for molecular assays and performed phase-in verification according to established guidelines.
- Complied with company quality assurance policies and document QA activities including instrument and procedural calibrations and maintenance.
Associate Scientist
Millennium Health
San Diego, California
10.2013 - 07.2016
- Responsible for assisting the Pharmacogenetics Laboratory (PGT) operation by supporting efforts in research and in the production activities, in accordance with established SOPs and QA measures.
- Responsible for the coordination and management of multiple validations.
- Established and validated Perkin Elmer MSM1 for DNA isolation to be used for production.
- Performed digital PCR using the Fluidigm platform for both gene expression and allelic discrimination.
- Established and validated Integra VIAFLO hand robotics for DNA quantification to be used for production.
- Established, validated, and designed new Pharmacogenetic assays to be used for testing and conducted training of new methods to laboratory staff.
- Worked closely with General Supervisor to design and perform experiments focusing on process improvement and optimization.
- Prepared validation reports, drafts, SOP's and training documents.
- Served as liaison between the PGT lab and various sales representatives regarding new instrumentation.
Research Associate
Bio-dx Inc
San Diego, California
06.2011 - 10.2013
- Assisted in the development and validation of genetic assays for non-invasive prenatal genetic screening during early gestation to be used in a CLIA certified laboratory.
- Helped design assays for multiple Skeletal Dysplasias and Trisomy 21.
- Performed real time qPCR for assay development and mutation detection using ABI 7900.
- Performed digital PCR using the Raindance platform for mutant allele detection, gene expression, copy number variation, and SNP measurement.
- Performed digital PCR using the Fluidigm platform for both gene expression and allelic discrimination.
- Extracted and isolated DNA from whole blood and tissue samples.
- Explored methylation of fetal DNA using immunoprecipitation and methylation specific PCR.
- Operated and maintained Hamilton Star Robotics and QIAsymphony SP.
- Served as liaison between team and various collaborating companies.
Technologist I
GeneDx, DNA Diagnostics Lab
Gaithersburg, Maryland
05.2010 - 05.2011
- Performed PCR, Sanger Sequencing, and Next Generation Sequencing in a professional CLIA/CAP certified laboratory setting for clinical patients, used for diagnostic testing in accordance with GeneDx's established SOPs.
- Prepared restriction enzyme digests and heteroduplex analysis to determine the presence/absence of a mutation in patient samples.
- Operated and maintained Hamilton and Beckman Robotics Platforms.
- Operated and maintained ABI 3730s, and set up sequencer runs in conformance with established ABI protocol.
Education
Bachelor of Science - Biological Sciences
University of Connecticut
Storrs, CT2010
Certificate - In Vitro Diagnostic Certification
UC San Diego Extension
La Jolla, CASkills
- Clinical Molecular Biology Techniques: Highly skilled in conducting a variety of clinical molecular techniques including Polymerase Chain Reaction (PCR) techniques, real-time PCR, digital PCR, Microarray, Sanger Sequencing, and Next Generation Sequencing
- Molecular Assay Design and Optimization: Knowledgeable in designing, developing, and optimizing molecular assays to ensure accuracy and efficiency
- Process Improvement Validations: Experienced in performing and managing multiple process improvement validations to optimize laboratory operations
- Team and Leadership Skills: Ability to develop strong and trusting partnerships with team members and executive leaders through excellent communication, mutual respect, active listening, and commitment to deadlines and deliverables
- Laboratory Information Systems (LIS): Experienced with LIS software validations in various testing environments and managing laboratory data and priority algorithms
Certification
MB (ASCP) Molecular Biology Technologist American Society for Clinical Pathology (ASCP)
License 3342
Clinical Genetic Molecular Biologist Scientist (CGMBS) California Laboratory Field Services,
License MTP01003396
Publications
- Zhu, Guang-dan, Ashley A. Brenton, Alka Malhotra, Bae J. Riley, Katherine E. Church, Frank E. Espin, Tanya A. Moreno, Jennifer M. Strickland, and Andria L. Del Tredici. "Genotypes at Rs2844682 and Rs3909184 Have No Clinical Value in Identifying HLA-B 15:02 Carriers." Eur J Clin Pharmacol (2015)
Timeline
Supervisor, Clinical Laboratory Scientist
Biotheranostics, A Hologic Company
11.2021 - Current
Lead, Clinical Laboratory Scientist
Biotheranostics, A Hologic Company
09.2020 - 10.2021
Clinical Laboratory Scientist
Biotheranostics, A Hologic Company
01.2018 - 08.2020
Clinical Laboratory Scientist
GenomeDx Biosciences
07.2016 - 01.2020
Associate Scientist
Millennium Health
10.2013 - 07.2016
Research Associate
Bio-dx Inc
06.2011 - 10.2013
Technologist I
GeneDx, DNA Diagnostics Lab
05.2010 - 05.2011
Bachelor of Science - Biological Sciences
University of Connecticut
Certificate - In Vitro Diagnostic Certification
UC San Diego Extension
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