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Work Background
Rx BandzDirector of Military Affairs
May. 2022Austin, Texas, United States
Rx BandzVice President Regulatory Affairs
May. 2022 - Mar. 2024
Eagle Health Analytics, LLCBusiness Development and Consultant for FDA, Dept. of Defense and Technology Development
Nov. 2019Austin, Texas Metropolitan Area
Military & Health Research FoundationRegulatory and Product Development Consultant
Nov. 2019 - Mar. 2022Austin, Texas Metropolitan Area
United States Air Force59th Medical Wing Science and Technology Office
Nov. 2019 - Feb. 2022Lackland Air Force Base, Texas, United States
Stoney Lonesome https://www.stonylonesomegroupllc.com/Venture Partner
Mar. 2019Wilton, CT
Military & Health Research FoundationVice President
Jan. 2016 - Nov. 2019Austin, Texas Area
Military Health Research FoundationDirector of Technology Development
Jan. 2016 - Nov. 2017http://www.militaryhealthresearch.orgThe Military Health Research Foundation (MHRF) is a (501)(c)(3) nonprofit organization dedicated to the advancement of military medical research to benefit the health and safety of the men and women of the United States Armed Forces.
• Project Management – Manage and support projects identified and funded by the Air Force Medical Support Agency and the Medical Modernization Panel: Includes, product development, commercialization, prototyping, intellectual property development, manufacturing, quality, technology development and commercialization pathway/planning, and regulatory support. • Project Administrative Support - Provide project level research administration and provide solutions to specific tasking such as research process consulting, equipment and staffing support, as well as pre-clinical and clinical trials support. Also, technology and project concept development and requirements analysis.
• Communication - Liaison and coordination with military research personnel and their support organizations. Work with research directors, researchers and support personnel to develop research technologies and projects. Communicate and coordinate with outside entities like academia and private industry or other government agencies to collaborate on these research efforts.
• Assessment – Work with the AFMSA Rapid Technology Transition Team and Advanced Development Team on identified pre-MDD projects or technologies. Assess and evaluate these projects for commercial pathway and military relevance. Work with RT2 team on the AFMSA portfolio identified by the Medical Modernization Panel Chair to determine investment viability and strategy.
• Coordination – Work with and support the Advanced Development team(s) at AFMSA, AFMESA, AF Medical Treatment Facility’s, USAMMRA/USAMMDA, JPCs, MRMC, DHA and/or any other military medical research agency or installation as required.
GenprexTechnical Progam Management Consultant
Oct. 2011 - Mar. 2012Austin TexasOverseeing the product development and contract manufacturing.
GLKK, Inc.CTO
Dec. 2009 - Dec. 2014GLKK is a healthcare company focusing on the needs of epilepsy victims and their caregivers. GLKK is in the process of designing /developing products that improve the quality of life for those suffering from seizures and improve the quality of care that their caregivers provide to them.
Innovate Texas FoundationConsultant
Dec. 2009 - Aug. 2010Providing assistance to innovators in applying for Department of Defense grants.
KayLee VenturesPresident
Aug. 2009Austin, Texas AreaKayLee Consulting provides industry, regulatory, technology commercialization, intellectual property, market and product development consultation to innovators and developing ventures. As a contractor to the Air Force Medical Service, KayLee Ventures, provides intellectual property and early product development expertise to the doctors, nurses and health care providers of the US Air Force throughout the world. We also assist in the technology transition between the AF Medical Service and private industry, hospitals, universities and other government agencies in the medical research field.
KayLee Ventures Inc.Consultant
Jan. 2009 - Dec. 2022Austin, Texas, United StatesDoD, FDA, CDC, VA and Commercial Medical Devices and Drugs
Univ. of Texas - UTENConsultant
Jan. 2009 - Dec. 2010
DPT LaboratoriesSenior Scientist
Jul. 2005 - Nov. 2007Developed products and processes for customers. Contract customers would bring a wide range of technologies: from undeveloped products to completed formulas already on the market. My group would then complete all levels of development or if the product was commercialized we would transfer technology from the existing manufacturing site. Executed all levels of pre-clinical, clinical and initial registration batches for creams, ointments, lotions, solutions and gels. Including over-the-counter products, prescription and DEA controlled substance products.
Managed the New Products/New Process Group group including hiring new employees, training, tracking metrics, employee development, direct interface with the customers and upper DPT management.
AlconSr. QA Analyst
Aug. 1986 - Jun. 2005Almost 20 years working in Process Development, QA, Production Management and Training.
PD - Scientist manufacturing clinical product and developing new products and new processes. Validation of aseptic processes, compounding processes and sterilization methods.
QA - Senior Analyst primarily working on validations of aseptic facility. Responsible for qualification and re-qualification of all aseptic processes in the FWN manufacturing facility. Including sterile filtration, bulk sterilization, sterilizer qualification, aseptic processing and aseptic facility and personnel. Also worked with FDA inspectors in relation to aseptic processing and qualifications.
Production Management - responsible for team assuring sterility of fill equipment, fill lines, aseptic suites and filling equipment setup.
Training - responsible for training of aseptic and production personnel, GMP training, TQM training and assorted other training needs. Received several training certifications.
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