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My passion is enabling translational medicine – helping take science from the bench to the bedside. I support emerging and early-stage technologies that impact human health or the environment in realizing their full potential. I am personally motivated by a desire to understand how things work, to discover new technologies and innovate and create optimized solutions, and to explore and share ideas and experiences that ultimately help improve our world. As an CMC operations and manufacturing development leader I have over 10 years of experience managing cGMP operations, facility design, technology transfer, and supply-chain management for cellular therapy development and commercialization. My mastery of diverse subjects brings versatility and talent to any team. I adapt quickly to new projects and the changing needs of any business. Being inquisitive and creative, combined with strong analytical skills and technical proficiency, allows me to innovate and engineer unique systems and solutions to enable improvements in operational efficiency and processing equipment and methods. My authenticity promotes building and maintaining relationships and allows me to develop and support strong teams. I emphasize transparent management, focusing on respect and consideration. I embrace work-life balance and encourage social responsibility and personal development. Functional Expertise: Operational excellence through pursuit of the Shingo model guiding principals Continual process improvement (PDCA, lean principles, reduction of waste, value adding, cost analyses, control charts) Technical innovation and intellectual property management Business development, implementing, Google Analytics and Ad-Words for organic growth Program and project management including design, budgeting, Gantt charts, cross-functional team building Training and development of new employees, interns, and for process transfer


Current Experience

  • Founder and Principal Consultant
    Since May 2014

    Created to formalize consulting services in the fields of biotechnology, food service, and outdoor recreation. Specializing in strategy, process optimization, R&D, cGMP, facility build-out, custom solutions, technical writing, formula/recipe design, and equipment and site maintenance.

Past Experience

  • Staff Scientist - Cord Blood Transplant Research Program Seattle, WA, United States
    November 2009 --- December 2015

    Hired by Dr. Colleen Delaney to help manage a $13.3M Biological Advanced Research and Development Authority (BARDA) contract. Designed and performed pre-clinical studies using a rodent model of acute radiation syndrome (ARS) to demonstrate a survival benefit of treatment with ex vivo expanded cord blood. Directed and performed all CMC activities for ATMP under cGMP to support 5 clinical trials performed under 2 IND applications. Supervised 4 research technicians and 2 post-doctoral fellows as well as mentoring rotating clinical fellows and summer undergraduate interns.

    My attention to detail and continuous product and process monitoring identified the impact of one ancillary material on product output; working with the vendor, I demonstrated it was lot variation of one component used in formulation of the ancillary material. Component screening and bulk purchase was implemented to solve the issue. This finding saved the projects of 2 colleagues using the ancillary material in different systems that also noted decreased product output but could not identify the source.

    Optimized the manufacturing process through negotiation of supply and purchase agreements and process development of a higher-throughput culture system, resulting in 30% materials cost reduction and 70% labor reduction. Developed and delivered training to successfully transfer manufacturing to an on-site cell processing facility. These improvements were vital to making the product commercially feasible.

    Integral to defining and pursuing a path toward licensure of the ATMP and the commercialization strategy, my business development helped identify commercialization partners and I was involved in early negotiation and strategy for out-licensing the technology to NOHLA Therapeutics, which launched in December 2015

  • Sales and Technical Specialist II Multiple
    August 2000 --- November 2010

    Bicycle and ski repair and maintenance and technical sales service for watersports, cycling, skiing, climbing, and camping.

  • Director of Technology and Business Development
    April 2008 --- July 2009

    Evaluated an optimized cryopreservation media for banking of hematopoietic progenitor cells from cord blood by collaborating with a regional blood bank. Streamlined the processing workflow of the blood bank cellular processing lab and published the results. Project managed a 3-stage preclinical safety study examining the safety and toxicology of intravenous infusion of biopreservation media as a vehicle for cellular therapies. Designed the study and worked with an external site to collect data. Orchestrated these studies for evidence to support strategic targeting of biorepositories and blood banks as new market segments, contributing to a 35% increase in sales for the year. Managed the Company’s intellectual property portfolio and negotiated supply and license agreements, leading to a 69% increase in licensing revenue over the prior year. Contributed to regulatory strategy and drafting of the Company’s first two FDA master file documents.

  • R&D Scientist
    September 2007 --- April 2008
    Following a short-term consulting agreement, I was hired into my first role with BioLife as a Research Scientist. My primary duties were to assist with research and development projects, performing bioassay release testing, interacting with customers as a technical reference, and supporting trade show activities that included preparing and delivering oral tutorials. Due to the dynamic nature of the business and the small size of the company, I was exposed to all facets of the business, where I quickly assimilated information and developed skills that highlighted an aptitude for business development activities and intellectual property management.

  • Graduate Research Fellow Nashville, TN, United States
    January 2002 --- January 2007

    In my first year, I was awarded 1 of 15 Vanderbilt-Ingram Cancer Center Support grants of $30K for a project I developed focusing on the relationship of focal adhesion and cytoskeletal proteins in hepatocellular swelling, which occurs after liver resection and stimulates liver regeneration, and their collective role in the proliferation of hepatocellular carcinoma. This led to further study of obesity and inflammation in the development of carcinoma secondary to steatohepatitis and culminated in the development of my thesis work on ischemia-reperfusion injury and liver metastasis of colorectal carcinoma.


Self Assessment :
AdaptabilityAnalytical thinkingApproachabilityAttention to detailAuthenticityCollaborationCommunicativeCreative thinkingCritical thinkingCuriosityDependabilityEfficiencyInnovative thinkingInterest in knowledgeProblem solvingStrategic thinkingService oriented


Self Assessment :
Animal models Cell biology Diabetes Lab scale batches Negotiation Phase I R&D Scientific writing21 CFR Part 11AnalysisAseptic ProcessingAseptic TechniquesAutomationBiological Drug DevelopmentBiomedical SciencesBioprocessingBiotechnologyBusiness DevelopmentBusiness StrategyCancerCancer ResearchCell Based AssaysCell CultureCell SignalingCellular Product DevelopmentcGMPChemistry, Manufacturing, and Controls (CMC)CleanroomClinical DevelopmentClinical researchClinical trialsCMCCMC Regulatory AffairsCommercializationCommunication SkillsContinuous ImprovementCurrent Good Manufacturing Practice (CGMP)Data AnalysisCustomer ServiceData ManagementDatabasesEnglishEntrepreneurshipExperimentationFACSFDAFlow CytometryGMPGood Laboratory Practice (GLP)Good Manufacturing Practice (GMP)ImmunologyInflammationKnowledge of the drug development processLaboratory ManagementLaboratory ResearchLife SciencesMammalian Cell CultureManufacturingMechanicsMedical writingMicroscopyMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft WordNegotiationPatentsPhase IIPhase IIIPhases of clinical development (phase I to IV)PhotoshopPreclinical developmentPre-clinical researchPreclinical ResearchProblem-solving methods and troubleshootingProblem SolvingProcess improvementProduct developmentProject ManagementPublic SpeakingQuality Assurance (QA)Quality Control (QC)Quality SystemsResearchRisk ManagementSalesScientific WritingScientific methodologySPSSStandard Operating Procedure (SOP)Start-upsStatistical Data AnalysisStem cell researchStem CellsSterile drug productsStrategySurgeryTeamworkTechnical SupportTime ManagementTrainingTranslational ResearchTranslational MedicineTroubleshootingWriting Study Procedures and SOPs
LinkedIn Assessment :
BiotechnologyCell biologyCell CultureBiochemistryLife SciencesStem CellsFlow CytometryImmunologyAssay developmentClinical trialscGMP manufacturingCommercializationPatentsBikesClinical researchCancerAseptic Techniquemolecular biologyStatistical Data AnalysisCellProtein chemistryLaboratoryELISAFDATissue CultureqPCRFluorescence MicroscopyWestern BlottingIn VitroMicrobiologyMicroscopyDNAImmunohistochemistryPharmaceutical IndustryClinical DevelopmentoncologyNegotiationStrategyCell Based AssaysSurgeryTransfectionImmunofluorescenceAnimal ModelsSignal TransductionImmunoprecipitationImmunoassaysApoptosisGel ElectrophoresisCell SignalingEntrepreneurship

Skills and Expertise

Self Assessment :
Chemistry Manufacturing and Controls (CMC) activitiescGMPDesign of Experimentsbusiness developmentCellular TherapyProvide support for scientific and/or technical projects Analytical skills Analyze data Build the CMC development plan Create SOPs Guide students Interpret data Write protocolsproject management


  • PhD in Cancer Biology from Vanderbilt University in 2007
  • BS in Biology, Chemistry from St. Norbert College in 2000


BrightOwl Assessment:
Self Assessment:
Elementary Proficiency

Work Preferences

  • Notice Period:
    2 weeks
  • Positions I am NOT interested in:
    Junior Laboratory Technician Laboratory Technician Research Technician
  • Locations I am interested in:
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position
    BrightOwl freelancer :    32 Hours per week
  • International:


    Expert has 1 publications (Will be avalible with full profile)

Area / Region

Leiden, Netherlands


Driving License
  • Yes