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Driven. For Flexibility.
Since the emergence of the COVID-19 virus and other new life-threatening diseases, it has never been clearer that the biopharmaceutical CDMO industry must be as flexible as possible in responding to the development and manufacturing needs of clients.
As a Senior Engineer on Samsung Biologics’ Drug Product Operations team, Rahyun Park sees flexibility as an integral part of her job in manufacturing, especially when unexpected issues arise. In her 5 years at the company, it’s been part detective work, part problem solving to identify risks and ensure GMP practices are upheld.
Rahyun discusses why being proactively reactive moves us towards client satisfaction and how her role in Drug Product plays a part in our “Driven. For Life.” mission.
What are your job responsibilities at Samsung Biologics?
My job here is as a lead investigator responsible for deviation management and Corrective Action and Preventive Action (CAPA) planning. When some unexpected issue occurs during manufacturing or in our facility, my job is to find the root cause of the problem and see if the problem has any adverse impact on our manufactured batch or our facility, and then come up with a CAPA plan that can prevent recurrence.
To deliver biopharmaceuticals more quickly while managing risks and regulatory demands, what are we doing to make our operations more integrated?
The Drug Product Team and all other departments work very hard together to achieve the same goal, which is providing quality products in a timely manner.
In order to meet the desired timeline, Samsung Biologics identifies most of the risks ahead even before a new product is introduced. That is possible because [we] incorporate all the risks from all previous products in a database, and we also assess any new updates in regulatory demands and promptly reflect them in our site.
Why is flexibility so important in drug product operations? What does this ultimately mean for our clients?
As drug product is the final manufacturing step before it goes to the patient, each manufacturing process is very different from product to product. There are stainless steel systems and single use systems, liquid product and lyophilized product, from small vial to large vial, and so on. To be able to manufacture all these kinds of products to be distributed over the world, flexibility in the DP line is very essential. With this flexibility, we can fulfill our client’s needs, which is one step forward to client satisfaction.
What do you think is Samsung Biologics’ greatest achievement in DP so far?
Samsung Biologics Drug Product has been approved from multiple regulatory agencies, including the FDA and EMA. It meant a lot for us, since it actually proves our capability. This achievement could only be made through our one-team mindset that embodies both the GMP (Good Manufacturing Practice) mindset and DP line flexibility that can meet our clients’ needs with the drive for success.
What aspect of your job do you think has added the most value to the company’s long-term goals and why?
As a lead investigator, it’s the in-depth investigation to be performed to find the true root cause. Finding a true root cause makes it possible to have a feasible Corrective Action and Preventive Action plan. With a solid and feasible plan, I can contribute to decreasing deviations and increasing the quality of our batches and ultimately the patients’ safety, which is part of our culture of being “Driven. For Life.”
What makes Samsung Biologics’ culture unique?
Samsung Biologics is pursuing a workplace where everyone has an equal voice regardless of job title. We call each other as ‘Pro’ [Professional], which makes it much easier to ask for help regardless of your job title or how much experience you have.
When you hear the phrase "Driven. For Life.", what comes to mind?
For me, I think Samsung Biologics is moving forward to seek a more ultimate goal. As a CDMO company, we manufacture products that are asked for, but those ‘products’ here are actual ‘drugs’ that can help patients to achieve a better life. So, with that slogan, I think we are getting to see more value in our products, expanding our vision to our clients, patients and even for all of humanity. Especially at this time in the gloomy pandemic era, to be able to participate in saving people’s lives in a certain way makes me feel very proud of myself and my company.
Related Contents
Whitepapers Establishing Turnkey Tech Transfer Processes For Drug Product
YouTube Reinventing the Client Experience: Drug Product Services at Samsung Biologics
Since the emergence of the COVID-19 virus and other new life-threatening diseases, it has never been clearer that the biopharmaceutical CDMO industry must be as flexible as possible in responding to the development and manufacturing needs of clients.
As a Senior Engineer on Samsung Biologics’ Drug Product Operations team, Rahyun Park sees flexibility as an integral part of her job in manufacturing, especially when unexpected issues arise. In her 5 years at the company, it’s been part detective work, part problem solving to identify risks and ensure GMP practices are upheld.
Rahyun discusses why being proactively reactive moves us towards client satisfaction and how her role in Drug Product plays a part in our “Driven. For Life.” mission.
What are your job responsibilities at Samsung Biologics?
My job here is as a lead investigator responsible for deviation management and Corrective Action and Preventive Action (CAPA) planning. When some unexpected issue occurs during manufacturing or in our facility, my job is to find the root cause of the problem and see if the problem has any adverse impact on our manufactured batch or our facility, and then come up with a CAPA plan that can prevent recurrence.
To deliver biopharmaceuticals more quickly while managing risks and regulatory demands, what are we doing to make our operations more integrated?
The Drug Product Team and all other departments work very hard together to achieve the same goal, which is providing quality products in a timely manner.
In order to meet the desired timeline, Samsung Biologics identifies most of the risks ahead even before a new product is introduced. That is possible because [we] incorporate all the risks from all previous products in a database, and we also assess any new updates in regulatory demands and promptly reflect them in our site.
Why is flexibility so important in drug product operations? What does this ultimately mean for our clients?
As drug product is the final manufacturing step before it goes to the patient, each manufacturing process is very different from product to product. There are stainless steel systems and single use systems, liquid product and lyophilized product, from small vial to large vial, and so on. To be able to manufacture all these kinds of products to be distributed over the world, flexibility in the DP line is very essential. With this flexibility, we can fulfill our client’s needs, which is one step forward to client satisfaction.
What do you think is Samsung Biologics’ greatest achievement in DP so far?
Samsung Biologics Drug Product has been approved from multiple regulatory agencies, including the FDA and EMA. It meant a lot for us, since it actually proves our capability. This achievement could only be made through our one-team mindset that embodies both the GMP (Good Manufacturing Practice) mindset and DP line flexibility that can meet our clients’ needs with the drive for success.
What aspect of your job do you think has added the most value to the company’s long-term goals and why?
As a lead investigator, it’s the in-depth investigation to be performed to find the true root cause. Finding a true root cause makes it possible to have a feasible Corrective Action and Preventive Action plan. With a solid and feasible plan, I can contribute to decreasing deviations and increasing the quality of our batches and ultimately the patients’ safety, which is part of our culture of being “Driven. For Life.”
What makes Samsung Biologics’ culture unique?
Samsung Biologics is pursuing a workplace where everyone has an equal voice regardless of job title. We call each other as ‘Pro’ [Professional], which makes it much easier to ask for help regardless of your job title or how much experience you have.
When you hear the phrase "Driven. For Life.", what comes to mind?
For me, I think Samsung Biologics is moving forward to seek a more ultimate goal. As a CDMO company, we manufacture products that are asked for, but those ‘products’ here are actual ‘drugs’ that can help patients to achieve a better life. So, with that slogan, I think we are getting to see more value in our products, expanding our vision to our clients, patients and even for all of humanity. Especially at this time in the gloomy pandemic era, to be able to participate in saving people’s lives in a certain way makes me feel very proud of myself and my company.
Related Contents
Whitepapers Establishing Turnkey Tech Transfer Processes For Drug Product
YouTube Reinventing the Client Experience: Drug Product Services at Samsung Biologics