Andrew Ditto

About Andrew Ditto

Experienced pharmaceutical and medical device developer. Skilled in meaningful innovation, medical device development, pharmaceutical development, nanotechnology, biotherapeutics, management, patent writing, clinical research, and analytical method development & validation. Strong product management professional with a Doctor of Philosophy (Ph.D.) in Biomedical Engineering.

Experience

1. Director of Engineering, Research and Development, and Chief Scientist

   Gebauer Company

   Jan 2025 — Present · Cleveland, OH, US

   Innovation:Leads the cross-functional team efforts for new products, product improvement, and process improvements. Intellectual Property and Product Development:Manages the patent and trademark portfolio including the authoring of 5 provisional patents and 2 full patent applications for new medical devices, including 2 product launches and 2 510(k) clearances. FDA Design Control for Medical Devices:Leads the R&D efforts to follow all FDA 21 CFR Part 820 and ISO 13485 design controls for medical devices including design plan, design inputs, design outputs, design verification testing, design validation testing, design transfer, and process validation.Analytical Method Development and Validation:Leads the method development and validation for analytical methods on gas chromatography and other laboratory equipment.Clinical Research:Serves on the clinical research team that coordinated with external researchers and principal investigators with designing clinical protocols and running clinical trials.Business Development:Leads cross-functional team that strategizes for growth including acquisitions and strategic partnerships by evaluating intellectual property, regulatory compliance, technical expertise, and overall valuation. R&D and Capital Expansion:Part of team that implements infrastructure expansion for new products.Process Validation:Leads cross-functional team that implements manufacturing changes and the validation of the changes.

Education

• The University of Akron

  Doctor of Philosophy (Ph.D.), Biomedical Engineering

  2006 — 2010

• The University of Akron

  Bachelor's degree, Biomedical Engineering

  1999 — 2004

• The University of Akron

  Master of Science (M.S.), Biomedical Engineering

  2004 — 2006

Skills

• Biomedical Engineering
• Medical Devices
• Biomaterials
• Product Development
• Solidworks
• Mechanical Testing
• Engineering
• Product Design
• Mathcad
• Statistics
• Validation
• Laboratory
• Assay Development
• Drug Delivery
• Drug Discovery
• Design Control
• Business Development