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.
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.
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.
AdaptabilityAnalytical thinkingApproachabilityAttention to detailAuthenticityCollaborationCommunicativeCreative thinkingCritical thinkingCuriosityDependabilityEfficiencyInnovative thinkingInterest in knowledgeProblem solvingStrategic thinkingService oriented
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
Skills and Expertise
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
Expert has 1 publications (Will be avalible with full profile)