I’m a Director of Program Management with a wide variety of competencies relevant to product development for the IVD/life science/biotechnology instrumentation industry. I’m most comfortable leading a multi-disciplinary team, from concept development to manufacturing, in the rapid development and optimization of cutting-edge instruments. I possess a wide range of skills which best position me to lead multi-disciplinary groups. These include mechanical design, prototype fabrication, integration skills, project management skills, electronics and optics knowledge, experimental design and analysis, molecular biology techniques, software control, and microfluidic design. Outside of specific technical skills, I have a strong background in operations, business development, and process development and improvement. I received my PhD working on life science instrument development, and I maintain a Project Management Professional (PMP) certification and a Regulatory Affairs Certification (RAC-US). I am currently a member of the Regulatory Affairs Professionals Society, The Project Management Institute, and the International Council on Systems Engineering. Currently, I am working in Ximedica as a Director of Program Management, across a variety of projects, developing instruments for the biotech industry. I lead all of my projects technically, as well as managing large teams of people and multi-million-dollar budgets. I have worked extensively in the molecular space, developing instruments for next generation sequencing, library preparation for sequencing, high-throughput genotyping systems, and sample-in-answer-out molecular diagnostics instruments.
Paul Fleming is a Director of Program Management with 12.8 years of experience in the IVD/life science/biotechnology instrumentation industry. He is skilled in experimentation, biomedical engineering, microfluidics, molecular biology, and R&D. Based in the United States, Paul is known for leading multi-disciplinary teams and optimizing cutting-edge instruments. He has a strong background in operations, business development, and process development. Currently, he is working at Ximedica as a Director of Program Management, where he oversees various projects in the biotech industry.
Providence,Rhode Island,United States
Veranex brings together best-in-class expertise in product design and engineering, medical device evaluation, clinical development, data management, regulatory, and market access to deliver an integrated and comprehensive solution from concept to commercial success. At Ximedica (now a part of Veranex), we transform bold ideas into life-changing innovations. Healthcare companies partner with us to strategize, design and develop medical devices and diagnostics because we are where the future is created.
Los Gatos,California,United States
Accel Biotech is now a part of Ximedica! Follow the Ximedica LinkedIn Company Page for all company news and industry updates. Ximedica’s Diagnostics Center of Excellence is located in the Silicon Valley. XimedicaDx is a fully integrated product development firm focused on bringing life science and diagnostics technologies from first concept to market launch. For over 30 years Ximedica has led the industry in unearthing new opportunities for clients, solving difficult development challenges, delivering cutting edge innovative solutions, and adding considerably to patent counts. Our clients break into new markets or forge entirely new ones, are heralded for their award-winning designs and consistently beat sales targets. We have long understood that innovation benefits from diversity. Highly experienced, cross-disciplinary teams guide development programs and serve as a retained knowledge base, which decreases the development timeline. Ximedica is committed to quality and regulatory assurance as demonstrated by our ISO 13485:2003 certification.
GenCell Biosystems is a developer of innovative biological testing instruments based in Limerick, Ireland. Founded in 2011, currently employs over 60 people. GenCell Biosystems was acquired by BD (Becton, Dickinson and Company) on Oct 13, 2014 BD-GenCell Biosystems provides biology with robust, high performance systems to perform analysis faster and at lower cost than is currently possible. BD-GenCell’s platform Composite Liquid Cell technology mirrors nature by performing tests within inert synthetic cells. These Composite Liquid Cells are an ideal environment to perform biological chemistry. Commercial instrument configurations include: • Library preparation for next generation sequencing • High throughput genotyping • High throughput DNA extraction • Live cell screening for compound testing To-date we have partnered with a number of established biotech companies to develop instrumentation for multiple applications. The company also collaborates with various worldwide universities to continuously develop innovative technologies.
Welcome to Curran Scientific. We provide and develop state-of-the-art fluid handling technologies for applications in biotechnology, medical devices and electronics. Whether you are at concept stage or require assistance developing more advanced devices, Curran Scientific has the technical expertise to progress even the most challenging project. We work with leading suppliers to develop the fully functional devices to suit individual client needs. With a deep understanding of a wide range of applications including medical devices, biotechnology, scientific instrumentation and electronics cooling, we also provide guidance based experience. With an experienced design and manufacturing team working from our development labs in Limerick-Ireland, Curran Scientific has already helped numerous companies to overcome technical challenges in developing or improving products.
Research And Development
In Vitro Diagnostics
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Paul Fleming works for Inflammatix, Inc.
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