IMG_7751
Position
Director of Scientific Affairs
Company
PharmaJet
Location
Golden Colorado UNITED STATES
Bio
My scientific expertise includes genetic engineering, design and development of human disease animal models, vaccine platform design, protein purification, and virology. I established GMP production for vaccine platforms and managed Quality Systems in drug manufacturing. I managed Regulatory and Clinical planning and execution for drugs, biologics and medical devices. I designed and managed ISO 13485 QMS, technical files, biocompatibility testing, and clinical evidence evaluations. I managed projects in product development, regulatory, clinical and Quality for biotechnology companies and medical device companies. Regulatory strategic planning, outreach, communication, and submission design and completion are a specialty. With PharmaJet my research and scientific knowledge, regulatory and clinical experience combined to help make significant contributions with needle-free injection technology for widespread vaccinations and the commercialization of DNA vaccines and therapeutics.