"Truly achieving form follows function is our goal for every project. Understand the business, and the process, and then design the facility to support and optimize. It’s surprising how often this basic process gets kicked to the curb in the rush to develop a floor plan for facility."
Rob offers more than 30 years of dedicated professional experience in all phases of advanced aseptic processing, including engineering, quality, qualification and manufacturing operations for the pharmaceutical and biotechnology industries. He has particular technical expertise in process mapping and optimization, barrier isolation technology, single-use disposable systems, potent material handling and containment, cleaning validation and CIP/SIP systems.
He has served in senior level management roles directing global engineering, design and manufacturing teams on fast-track design/build/qualification projects for clinical and commercial scale aseptic fill/finish facilities. He co-developed a flexible isolator configuration which allowed isolated formulation and fill/finish operations within a single isolator. As a director in the Global Quality Organization for a major pharma manufacturer, Rob developed quality and qualification documentation for cleaning, environmental and clean utility monitoring and equipment and process validation programs for sterile manufacturing operations worldwide.
Education
- B.S. - Chemical Engineering, Minor in Biochemical Engineering, Rutgers University
- Masters in Management, Stevens Institute of Technology
Professional Associations
- International Society for Pharmaceutical Engineering (ISPE)
- ISPE Sterile Product Processing Community of Practice, Steering Committee Member
Publications
- Roy, Rob. “Designing a Vaccine Facility,” Cell & Gene, September 17, 2020.
- Roy, Robert. “Single Use Disposables: Risk Reduction AND Operational Flexibility – Too Good to be True?” Pharmapro.com, March 2015.
- Roy, Robert. “4th Generation Aseptic Barrier Technology.” Pharmaceutical Processing, April 2013.
- Roy, Robert. "Case Study: Brazil fill/Finish: The role of CMO's in supporting Global Vaccine Production Needs." Pharmaceutical Processing, IPS Technologies Tours at INTERPHEX 2012 Supplement, March 2012.
- Roy, Robert. “Single Use Disposable Systems for Aseptic Fill Finish Facilities.” Contract Pharma, June 2011.
Presentations
- Roy, Robert, et al. “Traditional Syringe Filling Scalable Resilient Delivery Device”, Pharmaceutical Technology, June 24, Webcast.
- Roy, Robert, “Trends in Aseptic Processing”, IMA Life Aseptic Processing Symposium, June 2019, Bologna, Italy
- Roy, Robert. "Comparison of Barrier Isolators vs. RABS" ISPE India Annual Conference, 22 April 2017, Mumbai India.
- Roy, Robert and Jason Collins. "CGMP Aseptic Facility Design Based on Barrier Technology.” FDA Drug Investigator Training Program, 15 September 2015, Indianapolis, IN.
- Roy, Robert. "CGMP Aseptic Facility Design Based on Barrier Technology." FDA Drug Inspector Training Program DG 330 Active Pharmaceutical, Pre-Approval, and Sterile Drug Inspections, May 2014, September 2013, June 2013, Washington, DC.
- Roy, Robert. "CGMP Aseptic Facility Design Based on Barrier Technology." FDA Drug Inspector Training Program MP 302 Industrial Sterilization for Drugs and Devices, Portland, OR, June 2013, San Juan, PR, January 2013, Columbus, OH.
- Roy, Robert. "Case Study: Brazil Fill/Finish Facility." 5th Annual IPS Advanced Aseptic Tour, INTERPHEX, April 2012, New York City, NY.
- Roy, Robert. "Case Study: Brazil Fill/Finish: The role of CMO's in supporting Global Vaccine Production Needs." ISPE, March 2012, Frankfurt, Germany.
- Roy, Robert. “Single-Use Technology Application and Impact on Aseptic Fill / Finish Facilities.” ISPE, March 2012, Frankfurt, Germany.
- Roy, Robert. "Case Study: Brazil fill/Finish: The role of CMO's in supporting Global Vaccine Production Needs." ISPE, March 2012, Tampa, FL.
- Roy, Robert. “Single-Use Technology Application and Impact on Aseptic Fill / Finish Facilities.” ISPE, February 2011, Tampa, FL.
