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Our Story: Driven. For Quality.
Making the shift from a diagnostic kit researcher in a small Bay Area biotech firm to the quality sector in biopharma was a no-brainer for Sonya Lee. As a Senior Manager in our Quality Center, she finds the most value in her job when she’s working to improve quality processes for the company.
At Samsung Biologics, our Quality Control & Assurance teams provide support for the production of high-quality biopharmaceuticals through optimized systems and processes, ultimately to satisfy our clients, meet regulatory requirements, and ensure successful cGMP manufacturing operations.
Sonya breaks down why quality and process improvement are so important, and how they make up a core element of the company’s “Driven. For Life.” mission.
What are your job responsibilities at Samsung Biologics?
I’m responsible for leading two process improvement projects that integrate all of the different cross-functional groups within Samsung Biologics.
What does process improvement mean in the biopharmaceutical industry?
Process improvement, for me, is an assessment of where we currently are, how our business processes are set up, how our quality processes are set up, and figuring out a way to make both of those better in order to ensure that we can manufacture for our clients with speed and quality. Process improvements in the biopharma sector are very tricky because we have to ensure that we’re building agility into our processes, while maintaining quality for the fact of patient safety. If we have slow, inefficient processes, then our patients are impacted because we can’t manufacture product faster. If we compromise on quality as a result of business process improvement, then now we’re risking patient safety. So one of the big things that I focus on at Samsung Biologics is ensuring we balance those two, faster and better.
How does this ultimately impact our clients?
Building business processes that are more efficient and have quality impact our clients because by doing so, we’re able to take on more capacity. From an agility perspective, we’re able to manufacture for a more diverse population of clients, and a result, more patients. If we don’t have quality processes in place, then our clients are directly impacted because now, we’re going to be slowed down if we have to investigate those events.
How does data integrity and modernizing quality management go hand in hand?
In order to build a mature quality system, we need to have mature data integrity integrated into our systems. We can use the data that we’re generating electronically to make predictive analytics and to look at the data proactively instead of reactively, and by doing so we can help support our clients better…Everything we do at Samsung Biologics is really for ensuring that our clients are satisfied.
What makes Samsung Biologics’ culture unique?
I think one of the unique aspects of Samsung Biologics’ culture is there’s a sense of collective pride across management and employees. Our pride comes from the fact that first of all, we are one of the top companies in the country, and so a lot of people want to work here, and they are proud to work here. The second thing is from the work that we actually do. We manufacture products for patient safety, [and] for patient lives, and so as a result, we’re very proud of the things we do here and it translates in how hard everybody works.
What do you like most about working at Samsung Biologics?
One of the great things about Samsung Biologics is that we are always striving for better. For example, we just finished building Plant 3 a few years ago, and we achieved number 1 capacity at a single site, but Samsung Biologics wanted to do better so we’ve already broken ground with our new Plant 4. That type of mentality actually translates down all the way through every single employee that we have and it’s one of the great things about working here because you’re always striving for better.
When you hear the phrase “Driven. For Life.”, what comes to mind?
For me, the phrase “Driven. For Life.” brings to mind the idea of just trying to build a better world. In my role, this translates to ensuring we have quality processes integrated into everything that we do. By building processes that have quality while also maintaining speed, we’re able to bring safe products to patients faster and better.
Related Contents
Samsung BIO Insight Samsung Biologics embraces digitalization to provide next-level client satisfaction
Webinars BMWS 2020 | Quality Digital Transformation
Whitepapers Embracing Necessary Digital Transformation in Biomanufacturing
Making the shift from a diagnostic kit researcher in a small Bay Area biotech firm to the quality sector in biopharma was a no-brainer for Sonya Lee. As a Senior Manager in our Quality Center, she finds the most value in her job when she’s working to improve quality processes for the company.
At Samsung Biologics, our Quality Control & Assurance teams provide support for the production of high-quality biopharmaceuticals through optimized systems and processes, ultimately to satisfy our clients, meet regulatory requirements, and ensure successful cGMP manufacturing operations.
Sonya breaks down why quality and process improvement are so important, and how they make up a core element of the company’s “Driven. For Life.” mission.
What are your job responsibilities at Samsung Biologics?
I’m responsible for leading two process improvement projects that integrate all of the different cross-functional groups within Samsung Biologics.
What does process improvement mean in the biopharmaceutical industry?
Process improvement, for me, is an assessment of where we currently are, how our business processes are set up, how our quality processes are set up, and figuring out a way to make both of those better in order to ensure that we can manufacture for our clients with speed and quality. Process improvements in the biopharma sector are very tricky because we have to ensure that we’re building agility into our processes, while maintaining quality for the fact of patient safety. If we have slow, inefficient processes, then our patients are impacted because we can’t manufacture product faster. If we compromise on quality as a result of business process improvement, then now we’re risking patient safety. So one of the big things that I focus on at Samsung Biologics is ensuring we balance those two, faster and better.
How does this ultimately impact our clients?
Building business processes that are more efficient and have quality impact our clients because by doing so, we’re able to take on more capacity. From an agility perspective, we’re able to manufacture for a more diverse population of clients, and a result, more patients. If we don’t have quality processes in place, then our clients are directly impacted because now, we’re going to be slowed down if we have to investigate those events.
How does data integrity and modernizing quality management go hand in hand?
In order to build a mature quality system, we need to have mature data integrity integrated into our systems. We can use the data that we’re generating electronically to make predictive analytics and to look at the data proactively instead of reactively, and by doing so we can help support our clients better…Everything we do at Samsung Biologics is really for ensuring that our clients are satisfied.
What makes Samsung Biologics’ culture unique?
I think one of the unique aspects of Samsung Biologics’ culture is there’s a sense of collective pride across management and employees. Our pride comes from the fact that first of all, we are one of the top companies in the country, and so a lot of people want to work here, and they are proud to work here. The second thing is from the work that we actually do. We manufacture products for patient safety, [and] for patient lives, and so as a result, we’re very proud of the things we do here and it translates in how hard everybody works.
What do you like most about working at Samsung Biologics?
One of the great things about Samsung Biologics is that we are always striving for better. For example, we just finished building Plant 3 a few years ago, and we achieved number 1 capacity at a single site, but Samsung Biologics wanted to do better so we’ve already broken ground with our new Plant 4. That type of mentality actually translates down all the way through every single employee that we have and it’s one of the great things about working here because you’re always striving for better.
When you hear the phrase “Driven. For Life.”, what comes to mind?
For me, the phrase “Driven. For Life.” brings to mind the idea of just trying to build a better world. In my role, this translates to ensuring we have quality processes integrated into everything that we do. By building processes that have quality while also maintaining speed, we’re able to bring safe products to patients faster and better.
Related Contents
Samsung BIO Insight Samsung Biologics embraces digitalization to provide next-level client satisfaction
Webinars BMWS 2020 | Quality Digital Transformation
Whitepapers Embracing Necessary Digital Transformation in Biomanufacturing