Develop evaluation criteria for pharmaceutical products
Analytical Development Team
Asst.Manger Yoon A Park
Please tell us about your job at Celltrion.
As a member of the Analysis Method Development Team, I develop ways to analyze and evaluate the releases and safety of our antibody offerings and share them with the QC team. Part of my duty is to identify the physicochemical properties and biological activities of each product and select the most suitable analysis method for quality assessment. Furthermore, I optimize analysis methods and carry out conformance evaluations to see which factors affect the developed methods and how precise and accurate they are. My job also includes researching product characteristics, mechanisms, degeneration, the quality of nonclinical substances, and product safety.
What are the competencies and qualities required of your position?
By developing analysis methods, you are taking the first step for all the other analysis functions from process development to production / deployment / release / equivalency analysis. An issue with an analysis method may have tremendous repercussions, which is why it is critical and fundamental to develop methods carefully with a sense of responsibility. Other competencies include the ability to design experiments that efficiently reflect the variables and analyze the results from multiple angles. Moreover, as we are tasked with developing more analysis methods in the future, it would be better if you have the passion and courage to tackle and explore methods that you are not familiar with.
What was your most memorable episode at work?
What comes to my mind is the FDA audit for Herzuma and Truxima. During this audit, two analysis methods that I developed were suddenly announced as targets of the FDA audit. The auditor reviewed the development reports and asked me questions about them. Fortunately, I was able to answer those questions, but I learned my lesson and wrote my reports more carefully afterward. Looking back, I should have expected that my reports could be reviewed by an FDA auditor at any time, but, for some reason, it did not occur to me at that time. I still remember the tension I felt that day, and it has driven me to be more responsible in my line of duty.
Do you have any specific goals or visions? If so, what are they?
I often ask myself whether I am developing my own competencies while working at this company. Hence, I try to advance myself by departing from familiar ways. My vision is to become a trustworthy colleague that others can learn from and would like to work with.
Do you have anything to say to people looking for employment at Celltrion?
Celltrion’s products have to go through in-depth QA and cutting-edge evaluations to meet high-quality standards set by global regulators such as the FDA and EMA. We, the Analysis Method Development Team, are at the forefront of the company’s business, which can ultimately decide the future of the product. Given that, we have opportunities to experience and develop the most advanced analysis methods, which come with great pride and responsibility. I look forward to working with passionate new members with a sense of responsibility.