Are you a Scientist in the Pharmaceutical, Biopharmaceutical or Medical Devices industries?
Then you are probably asking:
- Does Quality-by-Design actually work?
- Or is it just another program like Lean or Six Sigma?
- How do I implement QbD successfully?
- How do I persuade my management?
- What is the first step?
As a QbD practitioner, I had the same questions and am trying to answer them as I test different elements of QbD.
Through our members’ successes and failures in QbD, you can save time by not having to repeat them yourself. There are many lessons learned and knowledge that you can share with your QbD team.
Who are You?
My name is Sun Kim. I currently practice Quality-by-Design, transforming how Product Development is executed in Biopharmaceutical, Pharmaceutical, Biologics, and Medical Device industries.
In addition, I teach at Stanford University. My focus of research is Lean Quality by Design.
I received my MS and PHD in Mechanical Engineering at Stanford University and was recently an Asst. Professor at Keio University in Japan. Prior to Silicon Valley days, I served in the Korean Army and worked at BMW AG in Munich, Germany, where my lifelong pursuit of “Product Development Methodology” began.
Why is an Engineer working in the Bio/pharmaceutical Industry?
Thanks for asking! When working at BMW, as a member of the elite “KREATIV” (Creative) team, my goal was to develop the best technologies and products for the automotive industry. However our approach was somewhat adhoc and heuristics-based. I knew there was a better way.
So I set my heart to learn how best products are developed across all industries. This led me to my PhD research at Stanford University.
Little did I know this would turn out to be more than just a graduate program. On top of the typical coursework, research and publishing, my schedule was packed with hands-on consulting/research projects with GE Healthcare, GE Aviations, Toyota, Nissan, Toshiba, Medtronic, Johnson & Johnson, Startup’s etc.
After contributing to the product development approaches for the Academia, Fortune 500 and Startup’s, I knew my heart was always with Health Care. So I returned to the benches and trenches.
For the last 10 years, I have been working in the Biopharmaceutical, Pharmaceutical and Medical Devices Industry, to make Quality by Design a reality.
So please join me in this Quality by Design journey.
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Together, we can change how drugs and therapies are developed for our patients and families.
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Previously I worked (full time or consulting) with:
The views expressed on this website are personal opinions and in no way reflect the position of any organization.
Quality by Design, Design Thinking, Product-Service-Systems Design, Systems Design Education, Design for X (i.e.Manufacturing, Lean Six Sigma), Lean Product Development, Design of Experiment (DOE), Lifecycle Engineering, Systems Modeling, Business Process Management, Biomedical Devices, Health care, Lean Six Sigma Master Black Belt (MBB), Project Management Professional (PMP), Agile Certified Practitioner (PMI-ACP), Certified Scrum Master (CSM)