Allison Holt, Ph.D.

adx44j@r.postjobfree.com

415-***-****

Leadership: Managed development and analytical validation studies at Contract Research Organizations and a team at the Fremont Thermo Fisher Scientific site, 2 direct reports, R&D lead for multiple projects. Technical project management experience. Assay Development: Extensive experience optimizing assays for DNA/RNA extraction, Real-Time PCR systems and capillary electrophoresis instrumentation (including Rapid DNA platform). Data Analysis Tools and Software: JMP16 and GeneMapper® ID-X. Design Excellence: Green Belt Certification for demonstrated proficiency in Six Sigma processes. Utilize six sigma processes while developing products including VOC, DOE, MSA and general product commercialization documentation.

Professional and Research Experience

Manager, Outsourcing, Jan. 2021-Dec. 2022

Genetic Testing Solutions Business, Genetic Sciences Division at Applied Biosystems, part of Thermo Fisher Scientific

Managed a team overseeing and executing development and Analytical Validation studies for the IVD market. Managed studies at multiple sites: Thermo Fisher Scientific (Fremont and South San Francisco locations) and a Contract Research Organization.

• R&D lead for sustaining project to increase customer adoption of TaqCheck™ SARS- CoV-2 Fast PCR Assay (qPCR assay for SARS-CoV-2). Managed instrument, saliva collection tube and 96-well plate bridging studies. o Designed studies, wrote protocols, trained laboratory operators and presented results at Design Review.

• Managed CRO activities for Droplet Digital PCR (ddPCR) validation. o Worked with R&D study lead to write the SOW, allocate resources and manage timeline.

• Managed development and AV studies for TaqMan™ SARS-CoV-2, Flu A/B, RSV RT- PCR Assay Kit and TaqPath Respiratory Viral Select Panel. o High level oversight of studies including writing SOWs, resource planning and ensuring on-time project completion.

• Managed Clinical Feasibility Study for qPCR assay for respiratory diseases at CRO. o Worked with Clinical Validation lead to plan study. Planned troubleshooting experiments and continuously reviewed data to ensure successful project completion. Reviewed draft Clinical Feasibility Study Report written by CRO and incorporated changes requested by internal team members including quality, regulatory and clinical validation team. High level oversight of project included managing timeline and communicating results. Staff Scientist/Scientist III, Oct. 2008 – Dec. 2020 Human Identification Group (Forensic Analysis Product Line) at Applied Biosystems, part of Thermo Fisher Scientific

• Developed SNP, INDEL and STR genotyping technologies for analysis of forensic casework sample types, paternity and database samples, including the AmpFℓSTR® NGM SElect™ Express PCR Amplification Kit and VeriFiler™ ID-X PCR Amplification Kit for use on capillary electrophoresis instrumentation. o Includes planning and executing early R&D, assay development and validation.

• Optimized DNA yields from forensic sample types from evolving DNA extraction technologies including PrepFiler BTA™ chemistry.

o Primarily executing early R&D feasibility studies. o Used robotics to optimize DNA extraction technologies for medium and high- throughput laboratories.

• Optimized PCR conditions to meet specific targets for sensitivity, amplification efficiency and inhibitor tolerance for Quantifiler™ Trio assay for use on Real-Time PCR systems.

o Included planning and executing early R&D, assay development and validation studies.

o Presented results of validation studies at conferences in United States, South Korea and Japan.

• Developed and validated novel technique for screening sexual assault samples for the presence of male DNA. Result is on-market Y-Screen protocol. o Presented results of validation studies at conferences and customer sites in United States and abroad.

• Optimized Rapid Intelligence protocol for RapidHIT ID System, a portable sample-to- answer genotyping instrument, resulting in improved capabilities for use with investigative leads samples.

Graduate Student Researcher, Sept. 2003 – Sept. 2008 Department of Molecular Biology and Biochemistry, U.C. Irvine

• Determined free energy change of protein-DNA & protein-protein complexes using molecular biology techniques and DNase I footprinting

• Performed global analyses of multiple protein-DNA binding isotherms

(>70 curves) and estimated nonlinear confidence intervals

• Constructed a comprehensive model for transcriptional activation based on in vitro biophysical chemistry results and in vivo beta-galactosidase published data for the CytR regulon in E. coli.

Research Associate/Scientist 1, Feb 2001- Sept. 2003 Applied Biosystems, Foster City, Ca.

• Perform early-stage R&D studies for the SNPlex™ assay, a SNP genotyping system performed on capillary electrophoresis.

Education

Ph.D. Biological Sciences, U.C. Irvine, 2008

B.S. Biotechnology, U.C. Davis, 2000

Professional Awards

• Thermo Fisher Scientific Exceed Award for incubation project, August, 2019

• Thermo Fisher Scientific Exceed Award for incubation project, August, 2018

• Life Technologies Global Employee Recognition Award for contribution to development of novel RT-PCR technology, June, 2014

• Edward Steinhaus Teaching Award, UC Irvine School of Biological Sciences, 2007

• DNA Award for research excellence at Applied Biosystems, August, 2003 Selected Publications

Volk, P., Holt, A., Chen, A., Hanson, E., Ballantyne, J. “Enhancing the sexual assault workflow: Development of a rapid male screening assay incorporating molecular non- microscopic sperm identification.” Forensic Science International: Genetic Supplement Series. December, 2019

Holt, A., Chao Wootton, S., Mulero, J., Brzoska, P., Langit, E., Green, R. “Developmental validation of the Quantifiler HP and Trio Kits for human DNA quantification in forensic samples.” Forensic Science International: Genetics 2016 Mar; 21:145-157 Holt, A., Senear D., "Cooperative Binding Energetics of CytR and CRP Support a Quantitative Model of Differential Activation and Repression of CytR-regulated Class III Escherichia coli Promoters." Biochemistry. 2013 19; 52(46):8209-18 Holt, A., Senear, D. “An unusual pattern of CytR and CRP binding energetics at Escherichia coli cddP suggests a unique blend of class I and class II mediated activation.” Biochemistry. 2010 49(3):432-42

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