Molecular Biology Quality Control

DAVID STILES

Silver Spring, MD 240-***-**** *********@*****.*** linkedin.com/in/david-stiles

QUALITY CONTROL Associate

Molecular Biology

Experienced Scientist with a strong background in biotechnology and clinical laboratory settings, specializing in molecular biology techniques, real-time qPCR, ddPCR, and molecular cloning. Skilled in assay transfer and development, with extensive experience handling infectious clinical specimens for DNA, RNA, and protein isolation. Proven track record of publishing research in prestigious journals, including the Journal of Human Genetics and Yeast. Adept at supervising laboratory technicians and leveraging strong interpersonal and communication skills to collaborate effectively with cross-functional teams. Committed to maintaining the highest standards of research quality and compliance and driven by a passion for advancing scientific discovery through teamwork and innovation.

Experience includes assay transfer and development utilizing molecular biology laboratory techniques.Extensive experience in the handling of potentially infectious clinical specimens for DNA, RNA, and protein for isolation and downstream biochemical analysis.

Research published in eight journals, including Journal of Human Genetics and Yeast.

Leverage interpersonal/communication skills in partnering productively with scientist-colleagues and lab staff.

PCR qPCR ddPCR DNA Sequencing Aseptic Cell Culture and Passaging

Gel Electrophoresis Statistical Analysis Molecular Biology

Research Publications Next Generation Sequencing (NGS)

PROFESSIONAL EXPERIENCE

NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER, Bethesda, MD 09/2024 to 05/2025

The clinical center of the primary agency of the United States government responsible for biomedical and public health research.

Clinical Research Scientist (part time)

Complete research objectives and support any ongoing research projects in the Transfusion Medicine Department. Write world-class caliber research articles for peer-review journals.

Spearheaded a clinical research study on Rh D-negative blood donors at NIH Clinical Center, analyzing over 5,000 samples to identify rare antigen patterns and inform transfusion protocols.

Co-authored and published three peer-reviewed articles in high-impact hematology journals, contributing to global knowledge in blood group genetics, and transfusion medicine.

Collaborated cross-functionally with hematologists, biostatisticians, and laboratory scientists to design and execute data- driven research supporting ongoing transfusion safety initiatives.

Delivered data-backed presentations to international panels, translating complex immunohematology findings into actionable recommendations that were adopted in multi-site clinical trials.

Enhanced research productivity through the optimization of data collection methods and the implementation of electronic lab notebooks, improving documentation accuracy and workflow efficiency.

MILTENYI BIOTEC, Gaithersburg, MD 09/2021 to 09/2024

A major provider of products and services that drive biomedical research and boost cell and gene therapy.

Assay Transfer & Qualification Scientist II, (full time)

Led the successful transfer of five molecular assays from Process Development to GMP-QC, ensuring seamless integration into QC workflows and compliance with ICH Q2(R1) guidelines.

Developed and qualified high-complexity biological assays by designing robust controls, acceptance criteria, and validation strategies, reducing assay variability.

Authored and executed comprehensive assay qualification protocols and final reports, supporting regulatory submissions, and meeting FDA and EMA audit standards.

Acted as a subject matter expert for sequencing analysis and primer design, generating reference sequences that improved assay specificity and reproducibility.

Streamlined quality control processes through data-driven optimization of assay validation steps, resulting in a 20% reduction in turnaround time, and enhanced lab efficiency.

Assay Transfer & Qualification Scientist I, (full time, independent contractor)

Executed end-to-end assay transfer from Process Development to GMP-QC, enabling timely release testing, and ensuring alignment with ICH Q2 validation standards.

Designed and qualified molecular assays by establishing appropriate controls, standards, and acceptance criteria, resulting in a 98% first-pass success rate.

Authored and implemented detailed qualification protocols and final reports, contributing to regulatory inspection readiness and audit compliance.

Supported sequencing-based assay development through reference sequence generation and custom primer design, improving detection sensitivity by 25%.

Collaborated with cross-functional teams to troubleshoot assay variability, streamlining QC workflows and reducing qualification cycle time.

AMERICAN GENE TECHNOLOGIES, Rockville, MD 04/2021 to 09/2021

Develops a platform for gene and cell therapy to create treatments for infectious disease, monogenic and cancers.

Laboratory Technical Supervisor, (full time, independent contractor)

Supervised and trained a team of 10+ laboratory technicians, increasing operational efficiency by 35% through the implementation of standardized workflows and continuous performance monitoring.

Oversaw routine and high-complexity testing under BSL-2+ conditions, ensuring strict adherence to CLIA, CAP, and OSHA standards in the processing of over 1,500 specimens weekly.

Conducted method validation, performance qualification, and reproducibility testing for SARS-CoV-2 assays, boosting testing throughput by 40% during peak diagnostic demand.

Led quality control and quality assurance efforts, reducing error rates by 25% through proactive root cause analysis and corrective action implementation.

Reviewed, approved, and released timely and accurate COVID-19 diagnostic results, maintaining 100% compliance with laboratory protocols and turnaround time targets.

COSMOSID, Rockville, MD 04/2020 to 01/2021

Improve Health by Unlocking the Microbiome.

Laboratory Consultant, (full time, independent contractor)

Rapidly promoted twice within one year due to consistent delivery on high-impact lab initiatives, including end-to-end management of qPCR assay validation for SARS-CoV-2 diagnostics.

Designed and implemented RT-PCR methodologies for coronavirus detection across clinical and environmental samples, contributing to a 50% increase in lab testing capacity.

Authored GLP-compliant SOPs for RT-PCR testing of wastewater and stool specimens, enabling laboratories to meet evolving public health surveillance needs.

Led hands-on training of lab personnel in qPCR workflows, achieving 100% technician competency within 30 days, and improving independent troubleshooting capabilities.

Developed and validated a qPCR-based 16S rRNA assay for bacterial DNA quantification, supporting accurate microbial profiling in NGS sample preparations.

NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER, Bethesda, MD 01/2012 to 03/2020

The clinical center of the primary agency of the United States government responsible for biomedical and public health research.

Clinical Research Associate (part time) – 10/2016 – 03/2020

Supported clinical research initiatives in the Department of Transfusion Medicine by analyzing genomic data from the 1,000 Genomes Project, contributing to population-based variant mapping.

Identified and cataloged the genomic coordinates and allele frequencies of over 120 blood group variants, enhancing donor- recipient compatibility algorithms in transfusion research.

Developed and optimized qPCR assays for accurate detection of RHD zygosity and Rh exon copy number, improving assay specificity, and reducing testing errors.

Co-authored a peer-reviewed publication in Transfusion (2018), providing novel insights into the continental distribution of blood group gene variants used in donor screening.

Collaborated cross-functionally with bioinformaticians, lab scientists, and clinicians to troubleshoot molecular assays, and ensure data integrity for clinical trial reporting.

Clinical Research Specialist (full time) – 01/2012 – 09/2016

Designed and executed laboratory experiments aligned with research objectives, applying statistical analysis methods such as ANOVA and regression to validate experimental outcomes.

Wrote and executed R scripts to perform descriptive and inferential statistical analysis on blood usage datasets, identifying trends that improved donor-patient matching strategies.

Developed interactive visualizations of transfusion data and genotype trends, enabling data-driven decision-making in prospective blood donor screening.

Co-authored a peer-reviewed publication in the Journal of Human Genetics (2018), detailing two large RHD gene deletions, contributing to the advancement of molecular transfusion medicine.

Collaborated with clinical teams to evaluate research findings, ensuring data integrity, and successful translation of laboratory insights into real-world transfusion protocols.

GENE LOGIC, Gaithersburg, MD 08/2008 to 01/2012

A leading integrated genomics company providing comprehensive genomic reference databases, life science lab information management solutions, GLP-compliant microarray services and essential research consumables.

Quality Control & Data Analyst (full time)

Developed and automated R scripts to perform quality control checks on Agilent, Affymetrix, and Illumina microarray datasets, reducing manual QC time.

Analyzed large-scale RT-PCR and microarray data for R&D and client projects, delivering high-accuracy insights that supported critical gene expression studies.

Standardized data visualization dashboards using R and ggplot2 enable the real-time detection of outliers and improve experimental reproducibility.

Operated robotic liquid handling systems to streamline DNA sequencing and RT-PCR workflows, increasing throughput by 30%, and minimizing pipetting errors.

Collaborated with cross-functional teams to validate data pipelines and align QC metrics with manufacturer thresholds, ensuring 100% compliance with quality standards.

NATIONAL EYE INSTITUTE, Bethesda, MD 4/2007 to 8/2008

Dedicated to vision research that saves sight and reduces visual impairment and blindness.

Research Associate (full time)

Led molecular and cell biology experiments supporting NIH-funded biomedical research, contributing to advancements in genetic screening and disease modeling.

Supervised and mentored post-doctoral fellows and lab staff on specialized techniques involving radioactive and biohazardous materials, ensuring full compliance with lab safety protocols.

Designed and implemented high-throughput assays for retinal dystrophy screening, leading to co-authorship in Investigative Ophthalmology & Visual Science (2011).

Co-authored a peer-reviewed publication on pathogenic mutations in REP1, offering novel functional insights, published in Mutation Research (2009).

Collaborated with senior investigators to streamline experimental design, data analysis, and manuscript preparation, accelerating project timelines.

NATIONAL INSTITUTE OF DIABETES, DIGESTIVE, AND KIDNEY DISEASES, Bethesda, MD 1/2003 to 1/2007

Conducts and supports research on many of the most common, costly, and chronic conditions to improve health.

Technologist / Research Assistant (full time)

Executed complex molecular biology assays and maintained detailed test records, supporting data accuracy for scientific presentations and peer-reviewed publications.

Identified and resolved technical anomalies affecting experimental outcomes, improving assay reliability, and reducing repeat testing.

Co-authored a high-impact study on microarray platform discrepancies, published in BMC Genomics (2007), contributing to improvements in transcript-level probe annotation.

Participated in research revealing cellular toxicity of long CGG-repeat tracts, published in FEBS Letters (2005), advancing the understanding of Fragile X premutation alleles.

Planned and carried out experimental designs aligned with research objectives, enhancing lab productivity, and ensuring compliance with quality control standards.

EDUCATION

Master of Arts – Biological Sciences – Marshall University – Huntington, WV

Bachelor of Science – Biological Sciences – Marshall University – Huntington, WV

TECHNICAL SKILLS

Adobe Photoshop Adobe Acrobat Microsoft Office Suite JMP R

PROFESSIONAL DEVELOPMENT

Introduction to Object Oriented Programming using Java Fundamentals of UNIX

MATLAB Fundamentals and Programming Techniques Statistical Methods in MATLAB

Basic Perl Programming Field Guide to NCBI Molecular Biology Resources

Introduction to Biostatistics STAT 200 Programming with NCBI BLAST

Biomek FX Fundamentals, 3.2 Software Course Biomek FX Methods Programming, 3.2 Software Course

Onsite Training and Application Development with Freedom Evo Liquid Handling Workstation

epMotion Automated Liquid Handling Systems Training Introduction to JMP

PUBLICATIONS / PRESENTATIONS

“Genomic Coordinates and Continental Distribution of 120 Blood Group Variants Reported by

the 1000 Genomes Project”

Celina Montemayor-Garcia, Panagiota Karagianni, David A. Stiles, Erika M. Reese,

Danielle A. Smellie, Debrean A. Loy, Kimberly Y. Levy, Magdalene Nwokocha, Marina U.

Bueno, Jeffery L. Miller, and Harvey G. Klein. Transfusion. 2018 Nov;58(11):2693-2704.

“Two large deletions at either end of the RHD gene extending beyond the gene’s limit and their red cell phenotypes” Kshitij Srivastava, David Alan Stiles, Franz Friedrich Wagner, and Willy Albert Flegel. Journal of Human Genetics, 63, 27–35 (2018).

“Two Large Intergenitc Deletions in RHD Involving Either Exon 1 or Exon 10”

Transfusion Abstract from the AABB Annual Meeting, Vol. 55, No. 3S, September 2015 Supplement.

“Two Large Intergenic Deletions in RHD Involving Either Exon 1 or Exon 10”

David Stiles, Kshitij Srivastava, Franz Wagner, Willy Flegel. AABB Annual Meeting (2015)

“Cover Art for the AABB Journal Transfusion,”

December 2014, Volume 54, Issue 12, David Stiles, Willy A. Flegel

“High-Throughput Retina-Array for Screening 93 Genes Involved in Inherited Retinal Dystrophy” Jin Song, Nizar Smaoui, Radha Ayyagari, David Stiles Sonia Benhamed, Ian M. MacDonald, Stephen P. Daiger, Santa J. Tumminia, Fielding Hejtmancik, Xinjing Wang

Investigative Ophthalmology & Visual Science November 2011

“Microarray studies on the genes responsive to the addition of spermidine or spermine

to a Saccharomyces cerevisiae spermidine synthase mutant”

Manas K. Chattopadhyay, Weiping Chen, George Poy, Margaret Cam, David Stiles and Herbert Tabor Yeast, Volume 26 Issue 10, 17 Aug 2009, Pages 531–544.

“The functional effect of pathogenic mutations in Rab escort protein 1”

Y.V. Sergeev, N. Smaoui, R. Sui, D. Stiles, N. Gordiyenko, N. Strunnikova, I.M. MacDonald

Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis

Volume 665, Issues 1–2, 1 June 2009, Pages 44–50

“EyeArray for Detection of Mutations in Common Genes Involved with Inherited Retinal Dystrophies” MacDonald IM, Smaoui N, Stiles D, Ben Hamad M, Strunnikova N, Hejtmancik JF. Association for Research in Vision and Ophthalmology Poster Presentation (2008)

“A detailed transcript-level probe annotation reveals alternative splicing based microarray platform differences”

Joseph C, Lee, David Stiles, Jun Lu, and Margaret C Cam, BMC Genomics 2007, 8:284

“Long CGG-repeat tracts are toxic to human cells: Implications for carriers of Fragile X permutation alleles”

Vaishali Handaa, Deena Goldwater, David Stiles, Margaret Cam, George Poy, Daman Kumaria, and Karen Usdina, FEBS Letters – 579 (2005) 2702–2708

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