Andrew Dunham

About Andrew Dunham

I am a senior executive who has established the vision and executed strategies for building a world class, global R&D organization. In my current role I am responsible for the science and technology at a pre-commercial medical device company striving to significantly improve patient outcomes in transfusion medicine. The challenges of this role have been to design and execute the strategies to convert a product concept into a commercializable device with compelling preclinical data that will support future regulatory approval and justify strong optimism and additional investment to support clinical outcome studies and global commercialization. I previously led more than 500 research professionals across the US, Asia and Europe comprising the following competencies:Analytical ChemistrySterilization Engineering and MicrobiologyLife SciencesEngineeringHuman Factors and Industrial DesignCell Biology and BiochemistryThis team characterized the products, developed the assays and produced the data informing design control and supporting global regulatory submissions aligned with the global regulatory strategies. We supported the development and sustenance of all products across all franchises at Baxter including medical device development including antimicrobial coatings, infusion pumps and electromechanical devices, recombinant and plasma-derived therapeutic proteins, devices and solutions for renal therapies, pre-mixed drugs and base IV solutions including container closure systems. The most rewarding part of this previous role was designing, developing and evolving the leaders and team members to provide technical competencies aligned with business strategies and objectives.Please contact me directly at: d•••••••@gmail.com

Experience

1. Chief Executive Officer

   Hemanext

   Aug 2023 — Present · Lexington, MA, US

Education

• University of Colorado Boulder

  PhD, Environmental Analytical Chemistry

  1990 — 1994

• Northern Illinois University

  BS, Chemistry

  1984 — 1988

Skills

• Regulatory Affairs
• Lifesciences
• Cross-Functional Team Leadership
• Gmp
• Product Development
• Life Sciences
• Strategy
• Product Launch
• Chemistry
• R&D
• Regulatory Requirements
• Medical Devices
• Capa
• Clinical Trials
• Biotechnology
• Leadership
• Research and Development (R&D)
• Validation
• Iso 13485
• Quality System
• Process Simulation
• CRO
• Commercialization
• Pharmaceutical Industry
• Fda
• Pharmaceutics
• Clinical Development