Homero Rey - Biotech & IVD Consulting, Rex Dx Biotech Consulting

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Network Power<100 people

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C-level Executive

🩺100%

Medical

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Work Background

TrilliumChief Scientific Officer

Jul. 2024Rockville, Maryland, United States

Goldbug Strategies LLCConsultant

May. 2024Gaithersburg, Maryland, United StatesProviding subject matter expertise to support regulatory strategies and submissions for LDT, IVD and CDx developers and manufacturers.

RexDx Biotech ConsultingFounder & Principal

Nov. 2023Rockville, Maryland, United StatesWe provide product and process analysis and optimization services for small and mid-size biotech companies. Our expertise is in identifying and clearing critical path bottlenecks, providing insightful analytics, and helping make data-driven decisions to move projects forward. We cover the entire R&D and Commercialization process, including Risk Analysis, Verification, Validation, Software Development, QC, Manufacturing, and Regulatory for RUO, LDT, IVD, and CDx products.

Molecular DesignsDirector, System Integration and Support

Apr. 2022 - Nov. 2023Birmingham, Alabama, United StatesDirected a team of two scientists to develop, validate, deploy, and support a variety of multiplex qPCR assay panels for human infectious disease and antibiotic resistance biomarker detection. ● Developed analytical verification and clinical validation study protocols for an IVD COVID-19/Flu/RSV respiratory qPCR panel. ● Managed instrumentation and reagent deployment for IVD clinical study. ● Supported new RUO Gastrointestinal Panel development from feasibility through manufacturing. ● Directed new diagnostic platform evaluations (including point-of-care systems). ● Supported successful ISO 13485:2016 certification. ● Provided ongoing manufacturing, commercial, and customer support for new and on-market products, including process improvement, NCR, and CAPA investigations. ● Managed major laboratory move, including new infrastructure and instrument deployment.

Thermo Fisher ScientificSr. Manager, Molecular Biology

Mar. 2020 - Apr. 2022Austin, Texas, United StatesBuilt a team of up to 14 assay scientists and automation engineers to support the rapid design, development, verification, validation, and deployment of the Amplitude Solution, a high-throughput COVID-19 testing platform capable of performing ~8,000 SARS-CoV-2 assays per day. Deployed platforms ran >10 million patient tests and generated >$1 billion in revenue in 2020 and 2021. ● Hired and managed 14 direct reports including six assay scientists, six automation engineers, and a lab manager, including four senior staff, within 1 year. ● Designed and built out two R&D laboratories, including BSL-2 spaces (~9000 sq. ft. total). ● Supported EUA submission for Amplitude Solution (EUA210257), granted 4/9/21. ● Spearheaded EUA supplement for additional sample type (saliva), granted 10/12/21. ● Provided ongoing customer support and platform development.

AsuragenSr. Scientist III, Manager

Feb. 2016 - Feb. 2020Austin, TXBuilt and managed a team of up to eight scientists to develop various CDx and molecular diagnostic assay kits (including reagents and software) for inherited genetic diseases and cancer under Design Control for both Research Use Only (RUO) and regulated In Vitro Diagnostic (IVD) applications. ● Led CDx assay development and validation team for an Alzheimer’s disease biomarker (TOMM40/ApoE) in support of a Takeda Pharmaceuticals therapeutic candidate. ● CDx assay and analysis consultant for ERBB2 (breast cancer) biomarker using next-gen sequencing technology. ● Development team member for CFTR (cystic fibrosis) and C9orf72 (amyotrophic lateral sclerosis) biomarker assays. ● Led Technical Team for a de novo 510(k) US-IVD (AmplideX Fragile X Dx & Carrier Screening Kit) using capillary electrophoresis fragment analysis (DEN190023 granted 2/21/2020).

Complete Genomics, Inc.Sr. Managing Automation Scientist

Nov. 2013 - Nov. 2015Mountain View, CABuilt, led, and managed a team of up to six automation scientists and engineers to develop a fully automated and integrated sample preparation system, under Design Control, as part of a novel ultra large-scale DNA sequencing platform (Revolocity System). ● Analyzed and optimized sample and library preparation workflow. ● Directed and designed automation hardware configuration, including custom development. ● Managed automation script design, development, testing, and implementation. ● Led the design and execution of vendor system acceptance testing, ensuring effective evaluation and compliance. ● Oversaw design, execution, and analysis of verification and validation studies. ● Supported and directed new automation laboratory buildout.

Genomic Health, Inc.Automation Scientist II

Nov. 2011 - Nov. 2013Redwood City, CAManaged a team of scientists and engineers in developing, validating, and commercially launching Genomic Health’s new RNA expression-based cancer assay (Oncotype DX® Prostate Cancer Test) in their CLIA and CAP-certified laboratory. ● Supervised up to 2 direct reports. ● Directed assay optimization and analytical validation studies. ● Supported clinical validation studies in close collaboration with clinical development team. ● Managed selection and qualification of new automation and instrumentation for clinical laboratory including new automation lab buildout. ● Supervised and performed programming for validation of liquid handling robot methods. ● Authored standard operating procedures and other process documentation. ● Trained clinical laboratory scientists on new methods and procedures. Project Team Lead Scale-up of an RNA purification process from FFPE tissues using a state-of-the-art integrated liquid handling work cell. ● Gathered system requirements and developed specifications. ● Produced system design and directed vendor evaluation. ● Designed and executed qualification and equivalence studies. ● Responsible for vendor relationships and overseeing system acceptance testing. Team Member Next-generation sequencing technology evaluation effort (Ion Torrent vs. Illumina) for RNA sequencing and mutation detection from FFPE tissues. ● Evaluated test data. ● Developed new workflow and automation procedures.

Pacific BiosciencesSr. Scientist

Mar. 2007 - Sep. 2011Menlo Park, CA● Optimized liquid handling protocols and system-level parameters for commercial next-generation single-molecule DNA sequencing platform (Sequel System). ● Validated new DNA sequencing chemistries for commercial release. ● Demonstrated feasibility of new DNA sequencing workflows. ● Participated in new feature development and integration (including hardware and software). ● Provided on-site assistance for new customer installations. Sr. Automation Scientist ● Evaluated, specified, and purchased over $500k of laboratory equipment for assay development and automation in support of a DNA polymerase and nucleotide analog screening program. ● Designed and managed buildout of new automation lab space. ● Directed automation of multiple manual bioassays, including protein quantitation, DNA polymerase activity and processivity, nucleotide analog affinity, selectivity, and photodamage. ● Organized and executed screening efforts that led to the identification of several novel DNA polymerase candidates. ● Managed up to two scientists (direct reports). ● Analyzed multi-factorial screening data, including statistical analysis methods such as recursive partitioning, to identify DNA polymerase hits. ● Executed, analyzed, and interpreted optimization experiments to maximize sequencing performance of novel DNA polymerase mutants.

Affymetrix, Inc.Sr. Automation Scientist

Jul. 2005 - Feb. 2007Santa Clara, CA● Automated the GeneChip Human Mapping 500K SNP Array Set sample preparation process on the Caliper Sciclone liquid handling platform. ● Managed and supervised a Research Assistant (direct report). ● Developed a scalable, bead-based DNA purification protocol for genotyping assays. ● Designed and executed experiments to determine assay and system performance. ● Performed statistical analysis and interpretation of experimental data. ● Presented experimental results at the group and project level. ● Collaborated with Instrument, Reagents, and Marketing groups for development projects.