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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

https://ispe.org/


Commercial Real Estate

https://www.lee-associates.com/


Building Systems

https://www.trinidadengineering.com/


Connect With Us

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