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Jessica Claire
  • Montgomery Street, San Francisco, CA 94105
  • H: (555) 432-1000
  • C:
  • resumesample@example.com
  • Date of Birth:
  • India:
  • :
  • single:
Professional Overview
To utilize my passion and experience in IVD development to benefit new technologies that will have a great impact on the quality of patient care and the future of healthcare. Highly adaptive, experienced, and self-driven *12 years IVD assay development experience *Experienced with: *feasibility, assay design and formulation determination *Troubleshooting *manufacturing transfer and QC specification *instrument integration *V&V *DSOPs *Regulatory communications *Management and leadership experience *Team player *Development of 5 CE and FDA approved IVD assays
Core Qualifications
  • GLP, GMP, GCP,
  • Target Capture, Transcription Mediated Amplification (TMA), Real-Time TMA, Hybridization Protection Assay (HPA) technology; RNA / DNA Isolation, PCR, rt(reverse transcriptase )-PCR, RT (real-time) -PCR, SSCP, RFLP, Southern Blot, Western Blot, Gel Electrophoresis, RNA / DNA Quantitation, Restriction Digests, ELISA, Microscopy, Aseptic Technique, UV / mass spec quantiation, Sequence Analysis, Genotyping Analysis, ABI 377 Series Sequencers, Tissue Culture;
  • MS Word, Excel , PowerPoint
  • Geneious, JMP, TableCurve, DOE,
  • Panther Real-Time Assay analysis tool
  • Instrument:
  • TIGRIS® DTS® System, PANTHER® DTS® System
Accomplishments
  • DTS 400, 402, and 802 instrument systems: Tecan EVO, SB100, LEADER HC+ Cas-1200 liquid handling system QIAxcel Fast Analyzer Stratagene instrument with MxPro software Clinical Diagnostic Assays: Gen-Probe: Aptima HSV 1 & 2, Aptima HPV, Aptima ATV, Aptima HPV 16, 18/45 GT Assays, PROGENSA PCA3 assay 
Education
Bachelors of Science: Molecular Biology Chemistry, Expected in January 2002
-
California State University - , Sacramento
GPA:
Molecular Biology Chemistry
Experience
Scientist II /Supervisor, 04/2014 - Current
Thermo Fisher Scientific Inc. Madison, WI,
  • Design, manage, and oversee completion of all studies necessary to complete development of assay; process transfer and QC release of assay; automated instrument assay integration; and CE/FDA submissions for Aptima HSV 1 & 2 (AHSV) assay.
  • Provide assistance, training, and present to outside groups in support of AHSV Assay.
  • Collaborate with other R&D groups, other functional areas, and external groups on project-related issues or studies to meet project requirements.
  • Contribute to the development of technical strategies to address project requirements.
  • Analyze associated lines of investigation and devise and recommend methods to resolve problems.
  • Design and develop assay, write DSOPs, develop sequencing analysis method, and assist with LIMS data management system development for composite PCR sequencing assay to support AHSV clinical trial.
Scientist I, 04/2011 - 04/2014
Planet Pharma Pittsburgh, PA,
  • Lead and managed efforts to perform feasibility for AHSV diagnostics assay incorporating both old and new company specific technology on instrument platforms.
  • Lead and executed complex V&V studies by writing protocols, completing statistical analysis of study data, and writing reports to support submissions to the FDA and other regulatory bodies for the Aptima HPV (AHPV) assay.
  • Lead efforts to design and validate sequence analysis method and successfully lead analysis of over 40,000 individual viral RNA sequences to fulfill FDA requirements -Work with clinical affairs department to operate as a site for Aptima TV (ATV) clinical trial and process and test over 5,000 clinical samples.
  • Regularly operate and maintain complex lab equipment including proprietary robotic instrumentation and develop and implement DSOPs for use of instrumentation - Present experimental findings and study results at department meetings.
  • Train and manage laboratory personnel.
Research Associate III, 03/2008 - 04/2011
City Of Hope Yorba Linda, CA,
  • Design and execute complex experiments to support CE mark and PMA submission for the Aptima HPV assay.
  • Write protocols, reports to support CE and PMA submission, and maintain accurate detailed documentation of experimental findings.
  • Operate and maintain complex lab equipment including robotic instrumentation.
  • Train personnel on DTS 400, 402, and 802 manual assay formats and use of TIGRIS instrumentation.
  • Regularly present data and project status to supervisor, team or department.
Research Associate II, 02/2005 - 03/2008
Gen-Probe Inc City, STATE,
  • Assist in development of APTIMA HPV assay and Progensa PCA3 assay.
  • Design and execute complex experiments to contribute to optimization and troubleshoot HPV multiplex system.
  • Design and execute complex experiments to contribute to optimization of Progensa (PCA3 / PSA) assay -Analyze data and incorporate findings to future experiments for further assay optimization.
  • Regularly give presentations on data and project status to supervisor and team.
  • Operate and maintain complex lab equipment including robotic instrumentation.
  • Write protocols, reports, and maintain accurate detailed documentation of experimental findings.
  • Train laboratory personnel.
  • Maintained detailed and accurate record of experimental findings.
Publications
Paul D. Swenson, Azza El-Sabaeny, Vanessa Claire-Moricz, Megan Allen, Anabel Groskopf, Alice Jiang, Damon Getman: "Evaluation of a transcription mediated amplification assay for detection of herpes simplex virus types 1 and 2 mRNA in clinical specimens." J. Clin. Virology 80 (2016) 62-67.
Awards
Skills
Aseptic Technique, data management, DTS, DNA, documentation, ELISA, experiments, functional, GCP, GMP, GLP, LIMS, mark, meetings, Excel, PowerPoint, MS Word, optimization, PCR, personnel, presentations, protocols, real-time, robotic, statistical analysis, supervisor, TV, Transcription, troubleshoot, UV

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School Attended

  • California State University

Job Titles Held:

  • Scientist II /Supervisor
  • Scientist I
  • Research Associate III
  • Research Associate II

Degrees

  • Bachelors of Science

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