Interview with Paul Ballering, Intravacc’s new Director QA/QC & EHS
Hello Paul, and welcome to Intravacc! We're pleased to have you here. Let's delve into your extensive professional background in the pharmaceutical industry, spanning over 25 years. Can you walk us through your journey before joining Intravacc?
“Certainly. My career began with a science bachelor's degree in Chemistry, leading me to a decade-long tenure at Diosynth in Oss. There, I contributed to R&D Production and Development of peptide syntheses and purifications in the chemical API division. In my final two years, I transitioned into CMC Program Management.
In 2008, I made a significant move to the Quality department in the biotech API division, which underwent name changes and eventually became MSD. Over the next 11 years, I took on various roles, including responsibilities in the release of API batches, Head of QC, Quality Lead for CMC development programs, and Head of QA Downstream Processing.
In 2019, I joined Synthon Biopharmaceuticals as Head of QC, later appointed Head of QA at the end of the year. During this period, the company evolved into a standalone entity named Byondis. We initiated several phase 1 clinical programs and also submitted a phase 3 program against breast cancer for approval with US and EU authorities.”
Your journey is truly impressive. Now, transitioning to your recent role as Director of QA/QC & EHS at Intravacc, how has your initial experience been in the first three weeks?
“It's been an engaging start! As I approach the end of my third week at Intravacc, I've prioritized onboarding activities, including introductory meetings with colleagues. The consistent theme has been a warm welcome, enthusiastic colleagues, and a wealth of knowledge. This reaffirms my belief that joining Intravacc is a wise decision as it embarks on a bright future.”
Recently, there have been various inspections at Intravacc. Could you provide some insights into those and how the team is addressing any identified opportunities for improvement?
“Absolutely. Just before I started, Intravacc hosted inspections from the Dutch Health Authorities (IGJ GMP inspection) and DNV (ISO14001:2015). Both were successfully completed, resulting in the extension of our GMP certificate and the reconfirmation of our compliance with ISO14001:2015. Identifying opportunities for improvement is a crucial aspect of these inspections, and we are actively executing on them. The DNV report is in, improvements have begun, and we anticipate the final report from IGJ in the coming weeks, prompting us to initiate necessary improvements as well.”
Looking ahead, preparations are underway for the upcoming inspection by the US NIH/NIAID. How confident are you, considering the recent IGJ inspection results, that this will be a success?
“With the positive outcome of the recent IGJ inspection, I am confident that our team will successfully navigate the upcoming inspection by the US NIH/NIAID from March 26-28, 2024. Two inspectors will be visiting to confirm our GMP readiness for manufacturing clinical trial materials for the IM19 Gonorrhea and EV D68 programs. I believe that, collectively, we will build on our recent success and make this inspection a success as well.”
Thank you, Paul, for sharing your experiences and insights. We wish you continued success in your role at Intravacc.
“Thank you. I'm excited about the opportunities ahead and contributing to the success of Intravacc in the realm of quality assurance, quality control, and environmental health and safety.”
