CIO: Chief Integrity Officer
Tana Montgomery, Clinical Manufacturing Operations Manager
Integrity can mean different things to different people. According to the Oxford Dictionary, integrity is the quality of being honest and having strong moral principles. I agree with this definition, but I would add that integrity is doing the right thing in a reliable, consistent and dependable way, serving as a role model and having a moral compass that does not waiver.
Integrity is the foundation of my role as a Clinical Manufacturing Operations Manager.
I work in the Clinical Manufacturing Facility (CMF) at Bayer’s campus in Berkeley, California. This is a highly regulated environment — for good reason. The medicines my colleagues and I develop are produced using live cell cultures and may be administered to patients by injection. We comply with a long list of policies and procedures to produce medicines that are safe and reliable for our patients.
My team and I follow Current Good Manufacturing Practice, a system for ensuring product consistency and quality. Our facility and equipment are qualified, raw materials are tested and released, personnel are highly trained and we remain audit ready at all times. Because our team may supply five or more drug substances per year for clinical trials — for different indications within hematology, oncology or cardiology — we also have strict processes and cleaning procedures to prevent cross contamination.
What’s my role in all of this? I ensure that our team and our CMF meet these regulatory requirements while meeting our business goals. You might call me our team’s CIO: Chief Integrity Officer.
Some people might be intimidated by a job with this level of requirements, but not me. Not my team. We’re motivated by our mission to develop medicines for use in clinical trials that may one day become Bayer’s next commercial product. We know that following these policies and procedures — doing the right thing in a reliable, consistent and dependable way — has the potential to improve the lives of patients.
