Microbiologist/Molecular Biologist

Annmarie K. Schramm

**** ********* *****

Sunset Valley, TX 78745

Cell: 512-***-****

*********@*****.***

SUMMARY OF PROFESSIONAL QUALIFICATIONS

Molecular Biologist/Microbiologist – Molecular IVD assay development. Nucleic acid sample prep workflow product development. DNA Sequencing, Sanger and NGS. Implementation of IDEO product design practices. Technology transfer and scale up expert in regulated markets. Statistical data analysis of large datasets to determine analytical false call rates.

Field Applications Scientist – expert customer trainer for qPCR, DNA Sequencing, Automation, and PLA– qPCR Protein Analysis. Builds and maintains customer relationships. Identifies new product opportunities and opportunities for improvement to reagent workflows, instrumentation, and software interface. Trains FAS from other regions. Generates reports in CRM database software, increasing visibility to the product team.

Expert at IVD product development, Gage R&R, Voice of Customer, workflow design, IDEO product design, Design of Experiments, verification and validation, technology transfer, quality systems development, QC protocol development, auditing, training, laboratory management, biosafety, GLP, GMP, new technology evaluation and troubleshooting.

Key technologies: customer training, VoC, human and agricultural pathogen diagnostics, IDEO principles, Biosafety Level III, nucleic acid sample preparation, qPCR diagnostics, DNA sequencing, PLA-qPCR Protein Analysis, RNA, Gene Expression profiling, 3D cell culture, 21 CFR part 11 trainer, immunoassay, lyophilization, GMP/GLP, SOP writing, regulatory compliance, and automation.

PROFESSIONAL EXPERIENCE

Envirologix Portland, Maine (05/2016-07/2016) Technology Development Senior Scientist

Prepares enzymes and investigates function in isothermal amplification reactions. Investigates quantitative properties of isothermal amplification. Determines sequence preference for nicking and polymerase enzymes.

ThermoFisher Austin, TX (09/2006-05/2016) Field Applications Scientist/ Senior Scientist, R&D

Minimized customer time to adoption and repeat sales for Pharma Analytics products by training customers in qPCR, DNA Sequencing, and Proximity Ligation Assays. Performed IQ/OQ on automation instruments and provided technical assistance to customers on method validation. Trained customers on reagent workflow, instrumentation, software (including 21 CFR part 11 compliance), and data analysis. Worked with software engineers to fix analysis software issues. Communicated customer contact through CRM database sofware, increasing awareness of customer issues or needs. Identified and reported unmet customer needs to Account Managers and Product Managers. Performed laboratory testing to replicate customer issues. Prepared samples from soil and sewage for microbial community analysis on the Ion Torrent. Developed sample-to-answer products for Gene Expression and SNP studies for the Cells-to- CT product line, incorporating IDEO design principles. Minimized sample processing time for stabilized blood samples. Developed methods to quantifiy tissue degradation through chemical lysis.

Leader, Austin Green Team: managed budget and events; prepared informative documents for employees.

Signature Science, LLC Austin, TX (07/2004-08/2006) Staff Scientist Corporate Biosafety Officer, Molecular Biology Laboratory Manager – Maintained compliance with Federal and State regulations. Authored SOPs and developed molecular biology lab dashboards. Trained employees on laboratory methods, developed proficiency panels. DNA Sequencing Expert on a sequencing project in Kazakhstan. Trained Kazakh scientists to extract viral nucleic acids, perform DNA sequencing, and evaluate sequencing data. Kazakh scientists successfully met project metrics and acquired additional DARPA funding. Audited national biodefense analytical testing laboratories to ISO 13485:2003 and ISO 17025 requirements. Provided expertise in qPCR to analytical testing laboratories.

Third Wave Technologies, Inc. Madison, WI (05/2003-05/2004) Scientist II Developed and commercialized IVD assays for Hepatitis C Virus on the InvaderTM nucleic acid detection platform. Investigated nucleic acid extraction methods for viral samples in clinical sample matrices.

Certified internal auditor for ISO 13485:2003 through RABQSA. Tetracore, Inc. Gaithersburg, MD (10/1999-05/2003) Scientist II Molecular Biology Division Manager, trained and coached employees. Developed FDA QSR compliant qPCR and RT-qPCR assays for the detection of human and animal pathogens. Technology transferred assays to diagnostic laboratories. GMP production of diagnostic assays for pathogen detection. Developement of positive control material.

Naval Medical Research Institute/Biological Defense Research Department Bethesda, MD (1996-1999) Laboratory Technician III

Developed qPCR and RT-qPCR assays to detect human and animal pathogens. Technical transferred assays to diagnostic laboratories. DNA sequencing expert. Manager, Sample Management Facility: Maintained Chain of Custody for diagnostic specimens, prepared QA/QC samples, and prepared samples for storage and shipping. Prepared schedules and budget.

Directed the renovation of a Biosafety Level III laboratory and co-authored the “Naval Medical Research Institute Instruction for Biological Containment Spaces”. Authored SOPs for the BL3 laboratory.

EDUCATION

Texas State University San Marcos, TX 2010

ACTiVATE entrepreneurial training program

The Johns Hopkins University Baltimore, MD 1996

Master of Science in Biotechnology

Bowling Green State University Bowling Green, OH 1991 Bachelor of Science in Microbiology and Environmental Science

CERTIFICATIONS

Certified Quality Auditor, American Society for Quality, certification number 33942 Registered internal auditor for the medical device industry through RABQSA, registration number TF-30-9726. Trained in QSR and ISO 13485:2003 regulations. Able to maintain security clearances.

PUBLICATIONS AND PRESENTATIONS

“Assessment of Microbial Population Diversity in Polymicrobial Research Samples by 16S Single or Multi-V Region Sequencing”, ASM Poster Presentation, American Society for Microbiology, E. Bolchakova, A. Schramm, A. Lackey, and P. Balachandran, 2015.

“Rapid Preparation of mRNA and miRNA from Stabilized Blood Samples”, Schramm and Fekete, poster presentation at Cambridge Healthtech Institute’s Science of Biobanking Conference, Providence, RI, December 2010.

“Superior Preservation of RNA in Tissue Stored in RNAlater® Solution”, Zeringer and Schramm, TechNotes Article, 16(3), Nov/Dec 2009.

“Rapid Array Comparison of Gene Expression Profiles in Snap-frozen, RNAlater® Solution- treated, and Ice-stored Tissue”, Schramm and Zeringer, poster presentation at Cambridge Healthtech Institute’s Biobanking and Advances in Gene Expression Profiling Conference, Philadelphia, PA, November 2009.

“Selecting an Additive for Applied Biosystems PowerSYBR® and FastSYBR® Cells-to-CTTM Kit to Minimize Reverse Transcriptase Inhibition of PCR”, Schramm, Harris, and Fekete, Poster presentation at Asilomar Conference, November 2008.

“Don’t bother Quantitating RNA for Gene Expression Analysis”, Schramm and Fekete, TechNotes Article 16(3), Dec 2008.

“Using SYBR® Green for Real-Time RT-PCR? Try SYBR® Green Cells-to-CTTM Kits”, Harris, Schramm, and Fekete, TechNotes Article, 16(3), Dec 2008.

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