Q1. What is your Team responsible for?

DS Manufacturing Team is responsible for manufacturing the drug substance (DS) required for biologics. The team involves an upstream process (USP) part that manufactures the target protein from cell culture, a downstream process (DSP) that purifies the target protein from the culture media, and a compounding part that formulates the DS stock solution to the final concentration for filling.

Q2. What is your role and its advantages?

I am in charge of the USP part. Although I initially chose this role based on my interest in cell culture, I now have a sense of purpose and responsibility about being in charge of the very first step of the DS manufacturing process.

Q3. When was the most rewarding moment while working at STgen Bio?

The most rewarding experience I had was when I successfully completed my first batch of the process I was in charge of. It was a time when I was still adjusting to the company, but focusing and successfully completing the USP helped me adapt both in and out of work.

Q4. What goal would you like to accomplish at STgen Bio?

Coworkers at STgen Bio are young and full of energy. We work together in a positive atmosphere, constantly learning and growing. My goal is to make sure the medicines produced by our team and company receive FDA approval so that we can continue to grow and expand. I believe I can accomplish this together with my colleagues.

Q1. What is your Team responsible for?

The main role of DS Manufacturing Team is to prepare biopharmaceutical drug substances (DS). DS production is largely divided into cell culture, purification, and compounding. For cell culture, the cell culture media is prepared, and cells are expanded to ultimately maximize protein production. For purification, the culture medium is purified, concentrated, buffer exchanged, and lastly filtered out to only contain the desired proteins. In compounding, the concentration and composition of the DS is adjusted by mixing with an appropriate amount of formulation buffer to make it suitable for administration in the human body. We are a team that strictly manages each and every manufacturing process in compliance with GMP to produce quality biologics

Q2. What is your role and its advantages?

I am responsible for the purification process (part of DSP) of DS manufacturing. The advantage of my role is that I get to see the entire biologics manufacturing process. Although I routinely manufacture biologics, the sense of accomplishment felt upon the completion of each batch is indescribable. I find fulfillment in knowing that I played a role in the process of creating products for patients, from cell to syringe.

Q3. When was the most rewarding moment while working at STgen Bio?

I remember the feeling of completing my first-ever batch. Going through the process of cell culture, purification, and compounding to obtain the final product gave me a great sense of accomplishment. Moreover, it gave me even greater satisfaction to see how the efforts of not only the DS Manufacturing Team, but also the cooperation from other departments, contributed to the successful results.

Q4. What goal would you like to accomplish at STgen Bio?

My goal is to acquire knowledge not only in DS manufacturing, but also other fields as well to become a well-rounded expert in the biopharmaceutical industry. I have come to realize that the DS Manufacturing Team is closely connected with other departments. I want to achieve my goal to have a broader perspective in biopharmaceutical production.

Q1. What is your Team responsible for?

Quality Assurance Team monitors activities within GMP facilities such as production and validation, and conducts a comprehensive evaluation based on objective data to ensure the products’ safety, stability, and effectiveness. We are a proactive team that also conducts self-inspection, withdrawals, oversight, and manages complaints.

Q2. What is your role and its advantages?

I am responsible for supplier evaluation and training management. Although supplier evaluation and training management are both a part of Quality System, I think the advantages of each role are different. In the case of supplier management, not only am I able to enhance my overall management skills by collaborating with suppliers from various fields, but also gain valuable insights into the overall production process and quality systems of partner companies through supplier on-site evaluation. For training management, I get to upgrade or develop various training programs that wi ll help workers effectively perform their duties. By training the staff myself, I am able to acquire valuable knowledge and techniques in training methods.

Q3. When was the most rewarding moment while working at STgen Bio?

The most rewarding moment was when I was a part of the Japan PMDA Inspection Preparation Team. After months of preparation, we successfully completed the inspection and received positive results. It was a great feeling to see everyone in the team acknowledging and congratulating each other for their hard work and dedication.

Q4. What goal would you like to accomplish at STgen Bio?

GMP training often takes place in a rigid atmosphere. For new employees, the topic of GMP can be unfamiliar and for existing employees, there may not be many training opportunities for areas outside of their specific job functions. My goal is to make GMP training accessible and easy to understand for all employees, by clearly and regularly conveying relevant knowledge. Additionally, I aspire to become a recognized GMP trainer for both, STgen Bio and Dong-A Socio Group.

Q1. What is your Team responsible for?

Quality Control Team is in charge of determining whether the product quality is appropriate through physical and chemical tests, microbiological tests, and biological tests before the drugs are supplied to patients. Quality is evaluated at all stages, from raw material warehousing tests and monitoring tests throughout the production process to product release tests. We also confirm the stability of biologics, and validate test methods.

Q2.What is your role and its advantages?

Within the QC Team, I am responsible for instrumental analysis. Instrumental analysis mainly deals with HPLC for physicochemical tests, and evaluates the identity, amount, and purity of the product. The advantage of this role is that I get to work with HPLC, which is an analytical instrument that is widely used within the biopharma industry, and obtain analytical experiences.

Q3. When is the most rewarding moment while working at STgen Bio?

It is when everyone works together to accomplish good results in the numerous inspections that I responded to while working at the company, such as the Japan PMDA inspection. I felt a sense of accomplishment knowing that the efforts made with my colleagues were not in vain when we received good inspection evaluations without any points of criticism.

Q4. What goal would you like to accomplish at STgen Bio?

I want to be a talent who contributes to the company's mission of becoming a global biopharma organization by working towards achieving EMA and FDA approvals through quality improvement. On a more personal note, I would like to achieve financial success so that I can purchase a nice home, but I believe these will come naturally.

Q1. What is your Team responsible for?

We are responsible for the operation and maintenance of STgen Bio’s manufacturing support equipment (electricity, air, water, HVAC, steam), preventive maintenance and troubleshooting of production equipment (related to DS and DP). Additionally, I ensure all team members take ownership of their responsibilities to prevent any deviations in production.

Q2. What is your role and its advantages?

I am responsible for Preventative Maintenance (PM). I conduct inspections before equipment operation to prevent problems and promptly address any issues that arise during operation to avoid production disruptions. In addition to gaining experience with the equipment, this job also allows me to learn about the procedures of other departments through collaboration, providing a diverse range of work experiences.

Q3. Could you tell us about the efforts that you made to get to where you are today?

I found that the knowledge required for repairing equipment in the field was quite different from what I had learned theoretically in school, due to the diverse types of equipment, tools, and accessories involved. Personal study and cumulative hands-on experience gained while working on the job has helped me overcome these difficulties.

Q4. When was the most rewarding moment while working at STgen Bio?

Since my primary duty is to manage the preventive maintenance of the equipment for the DP Manufacturing Team, I recall a particular instance where I had to fix their team’s equipment. The process took a period of two extensive days involving equipment repair, as well as implementing measures to improve the work method. I felt a great sense of satisfaction and accomplishment when the task was completed, and the thought "I did it" was prevalent in my mind.

Q5. What goal would you like to accomplish at STgen Bio?

My goal is to become an engineer that my team's equipment operators and workers can trust and rely on. Additionally, I would like to gain various experiences outside of equipment maintenance so that I can be a more well-rounded professional.

Q1. What is your Team responsible for?

IT Team manages the data integrity of digital information. We determine what systems and procedures to implement that will guarantee the validity and accuracy of our data.

Q2. What do you enjoy about your job?

Computerized systems have been widely adopted by various sectors of the biopharma industry to meet regulatory compliance and boost work efficiency. To ensure integrity of the data generated by these systems, policies must be established and enforced effectively. Being able to develop and manage policies by combining the requirements of regulatory authorities and IT technology offers a different appeal than traditional pharmaceutical industry jobs.

Q3. What are your impressions of the people at STgen Bio?

STgen Bio is filled with young and talented individuals, who are responsible, smart, and forward-thinking. We are constantly striving for ways to find the best solutions. It is a blessing to be able to work with such wonderful people.

Q4. What goal would you like to accomplish at STgen Bio?

Digital data integrity management cannot be achieved through the application of technology alone. It also requires the collective effort of both management and members of the organization. Therefore, my goal is to establish and maintain a culture of high standards for data integrity within STgen Bio.