Experience

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  United states department of defense

  Jun 2010 - Aug 2015

  Biologist/quality assurance laboratory supervisor

  • Supervised daily laboratory operations within a United States Navy facility. Concurrently established a climatology useful to conducting outdoor testing and educated test site managers in appropriate use of equipment and safety as well as maintenance.• Oversaw and directed a team of over 30 test site managers during an outdoor environmental release experiment in which the results were presented to Congress.• Maintained Quality Assurance through authorship of SOPs, adhered to regulatory requirements, and participated in audits.• Directed a team of 8 laboratory technicians, developed a training program, coordinated technician scheduling, and mentored staff.• Created preventative processes, conducted root cause analysis, and documented corrective action plans.• Conducted review and analysis of approximately 1,500 data points on a biweekly basis while checking for completeness and accuracy of records; compiled biweekly reports of results for outside parties.• Conducted DNA extractions, PCR, high throughput assays, media and reagent preparation, and other lab procedures using aseptic technique. • Experimentation with tissue cultures. • Developed and implemented a process to streamline sample preparation, resulting in a cost savings of $50K per year over the lifespan of a program lasting at least ten years for a minimum savings of $500K. Show less

• 

  Abbott

  Nov 2015 - Dec 2019

  • Lead efforts to create an automated data capture system to eliminate the need for sites to manuallyenter Clinical data into EDC.• Integrate IBM Clinical EDC system with Abbott proprietary source worksheets.• Provide key contributions to study planning, protocol development and review, and writing informedconsent forms.• Demonstrated ability to work on multiple high-complexity, fast-paced projects and ensure alignment across department leads on key issues.• Make decisions on issues or escalate as necessary while leading efforts to meet critical deadlines that suit business needs.• Communicate with study site regarding conduction of protocols, recruitment, documentation, andlogistics, as well as determine participant compensation and run debarment checks. • Compose and drive numerous Design Change Processes for both NPD and LCM projects. • Develop and nurture strong global cross-functional relationships, as well as external relationships, to produce a flawless workflow.• Oversee ordering of study supplies and inventory.• Lead R&D efforts for Hematology Point of Care testing device. Show less • Independently built and organized an R&D laboratory for hematology research and development from the ground up, which included training personnel, writing SOPs, setting up hazardous waste disposal, and obtaining necessary documentation.• Self-taught setup, operation, and troubleshooting of over 15 new lab instruments, including prototypes under development.• Trained team members on good laboratory practices, protocols, how to use equipment, and laboratory safety. • Routinely communicated with external collaborative companies to assure industry leading products.• Ordered and set up laboratory equipment and supplies as well as troubleshot equipment.• Performed design of experiments and routine testing, developed validation test methods, and made significant adjustments to already established protocols as necessary.• Placed laboratory orders, tracked inventory, resolved ordering discrepancies, and scheduled contract services.• Conducted routine maintenance and calibration of equipment to ensure accurate and consistent results Show less • Direct day-to-day implementation of quality assurance and compliance regulations for a billion dollar manufacturing company producing state of the art technology equipment for medical facilities. • Improved design quality through review and approval of verification and validation protocols as well as implementation of best practices for both software and hardware entities, resulting in 510(k) approval from the FDA.• Provided feedback to peers and management in various departments on Design Input Requirements, Design Specifications, and Functional Requirements; ensured compliance to these requirements and challenged protocol approaches, providing alternative solutions to protocol designs to mitigate risks when necessary.• Extensive experience in conflict negotiation and resolution.• Initiated a process to discover discrepancies prior to entry of documents into the Design History File, which resulted in a 20% lower error rate. • Instituted new staff and served as a point of contact for upholding compliance and interpretation with 21 CFR 820. Show less

  • Project Manager

    Nov 2017 - Dec 2019

  • Laboratory Manager

    Nov 2017 - Dec 2019

  • Quality Engineer

    Nov 2015 - Dec 2019
• 

  Caris life sciences

  Dec 2019 - now

  • Director - Molecular Operations Liquid Profiling

    Feb 2024 - now

  • Senior Manager - Molecular Liquid Profiling

    Dec 2022 - Feb 2024

  • Liquid Profiling Lab Manager - Molecular Operations

    Nov 2020 - Dec 2022

  • Molecular Laboratory Supervisor

    Dec 2019 - Nov 2020