“Getting a degree in chemical engineering, I thought I’d work at a refinery or a chemical plant. I was aware of the pharmaceutical industry but hadn’t given it much thought. Once I started in the industry, I was really interested in it. In that role, I was supporting instrument validation and method validation, and once I got the word ‘validation’ on my resume, there was always work. Over the years, I worked in facilities maintenance and validation before moving into quality.”
Now as Associate Director of Quality Engineering at Kite Pharma, Rod is responsible for commissioning, qualification, validation, and risk management for facilities, utilities, and equipment for a multi-viral vector manufacturing facility. He leads a commissioning, qualification, and validation team to generate site validation master plans, user requirement specification, risk assessments, and qualification schedule and protocols. “I oversee the jobs I used to do. I think it is beneficial that I worked as an engineer for years in all those disciplines. I have a better understanding of what it takes to do the job and of the impact differing changes or incidents can have in quality systems.”
“When I joined Kite Pharma, I was part of the team that basically built the plant I’m now at. We built the facility, qualified all the assets, brought it online and received FDA and European approval. I’ve worked on a lot of good projects, but bringing this from seeing the foundations poured to FDA approval was a great journey.”
“I’ve always enjoyed working in the pharmaceutical industry because we help people, we improve and extend the lives of people everywhere. The therapies that I’ve gotten to be part of, especially where I’m at now, it makes a significant improvement in people’s lives. We create viral vectors that are used in downstream manufacturing process. Right now, our chimeric antigen receptor T cell (CAR T) therapy is used primarily to treat leukemia and other types of blood cancers, but we are trying to expand our therapies into other therapeutic areas outside of cancer. I feel fortunate that at this point in my career, I get to be part of a new type of therapeutic class that I think will have a lot of growth in the decades to come. It is exciting to see what is possible.”
In addition to being chair of the Critical Utilities Community of Practice Steering Committee, Rod has been instrumental in the development of many ISPE guidance documents. He is co-chair of the team working on the revision of ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems and was on the authoring teams for the original ISPE Good Practice Guide: Good Engineering Practice, ISPE Good Practice Guide: Process Gases, Second Edition, ISPE Baseline Guide® Vol. 4: Water and Steam Systems, Third Edition, and ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems, Second Edition. He has also been active in ISPE’s San Diego Chapter.
