About Us
Chris O'Reilly
With over 30 years of experience in biotechnology operations and engineering, I am an independent advisor who specializes in confidential assessments of technical operations in support of operational streamlining and cGMP scale-up. I have a multi-disciplinary network of independent, seasoned professionals available to assist in specialized areas when needed. My mission is to provide insightful evaluations of the feasibility, compliance, risk, and value of various biotech products and processes, ranging from biologics and medical devices to human tissue products, aseptic processes and novel materials.
As an independent advisor, I offer a wide range of services, such as gross margin assessments, technical reviews, process and supply chain risk assessments, staff balancing assessments, on-site facility value evaluations, FDA inspection readiness reviews and capital project support. Prior to becoming an independent advisor, I was the Vice President of Operations, Facilities and Process Engineering at Organogenesis Inc. with P&L responsibilities for multiple sites and contract manufacturers .
Please click on the LinkedIn button at the bottom of this page for more detailed background information.
Past Project Examples
Onshoring Assistance for Medical Device
strategic planning for returning portions of overseas manufacturing to the United States
Existing Manufacturing Site Transition
biopharmaceutical acquisition establishing transitional site management, staff streamlining and significant gross margin improvements
New Biopharmaceutical Facility
site selection analysis, manage competitive bid process for design & construction, board level owner representation and reporting
Scale-Up of Autologous Cell Therapy
process mapping, site selection analysis, manage competitive bid process for design & construction, validation planning
Due Diligence Engineering Review for Overseas Product Acquisition
prescription drug - review engineering documentation for quality, supply chain risk analysis
Preparation for FDA Site Inspection
biologic - audit of production and engineering systems with focus on process change control
Additional Resources
Technical - Pharmaceutical Engineering
Commercial Real Estate
https://www.lee-associates.com/
Building Systems
https://www.trinidadengineering.com/