Astellas Pharma Inc. Recruit

• Q1What is your current job description?

  I study the method for the scale-up synthesis of drug substances, which is active pharmaceutical ingredients.

  In order to deliver pharmaceuticals to patients around the world, we must be able to scale-up synthesis of drug substances. Since the quality of pharmaceuticals directly affects the health of patients, a manufacturing method that can stably supply high-quality drug substances is necessary. In scale-up synthesis, it is also necessary to consider the environment and safety, and to aim for cost reduction.
  At the Chemical & Biological Technology Labs, we are developing manufacturing methods that enable the stable, safe, and low-cost supply of high-quality drug substances. We are responsible for work related to drug substances in a wide range of development phases, from lab-scale experiments to large scale manufacturing for commercial products and post-marketing life cycle management. In addition, we are able to be involved in operations necessary for the stable supply of drug substances, such as submitting applications to the regulatory authorities and managing starting material sources and manufacturing sites.
  I am in charge of small molecule drugs in the early stages of development, and developing manufacturing methods for the first chemical synthesis of drug candidate compounds on a kg scale. The drug substances produced will be used for formulation studies and clinical trials, so it is necessary to establish a manufacturing method that enables synthesis with a predetermined quality and schedule. Within a limited time frame, I search for appropriate routes and reaction conditions by repeating the cycle of hypothesizing, experimenting, and discussing. I also discuss with my colleague to get hints and obtain information through literature research, challenging myself to improve the manufacturing method to a high quality. When I was in university, I often thought only about the "target compound," hoping to synthesize it, but since joining the company, I have been able to think more deeply about "how to synthesize" compounds.
  I feel each job is worthwhile when I think that there are patients waiting for the drugs we synthesize.

• Q2When do you find work interesting or difficult?

  Synthesizing large quantities of drug substances is difficult, but also interesting and fulfilling work.

  I find the process of achieving scale-up synthesis both interesting and difficult. When deciding on a synthesis method in the laboratory, we consider many things. For example, the reaction conditions for high yield, whether the reaction proceeds in the same way each time, how to synthesize from even the cheapest starting materials, how to remove or reduce impurities, how to reduce the workload at the manufacturing site, and so on. There are many items to be considered, and I feel that it is difficult to choose a policy and selection for consideration. That said, I find research interesting when I can prove a hypothesis or find the cause of a problem.
  If I were to do chemical synthesis on my own, I would be limited to a few 10g scale at most. I was surprised to see how many people are involved in the safe and high-quality synthesis on the scale of several 10kg to several 100kg. For example, we work with an environmental safety team that confirms that the manufacturing process we have created is safe for operations, a quality assurance department that confirms that the quality of the drug substances can be assurance using the established manufacturing process and test methods, and the manufacturing site where is actually produced according to the manufacturing process. I feel a great sense of accomplishment when I succeed in synthesizing a large amount of drug substances as a result of our close collaboration with the relevant departments.

• Q3In your work, what challenges would you like to take on in the future?

  I would like to take on the challenge of working in a wide range of phases, from the early stages to commercial stage.

  I would like to become a process chemist with a broad perspective and would like to experience all the processes involved in the supply of drug substances. From synthesizing a small amount of a drug candidate compound to putting it on the market and managing its stable supply, I need to understand not only organic chemistry but also chemical engineering, safety engineering, application-related laws and regulations, and many other fields. Furthermore, in order to work smoothly as a team throughout the company, it is necessary to understand and consider the processes before and after my own department. Since many of the starting material manufacturers and manufacturing plants are overseas, communication in English is also important. In my second year with the company, I am still learning, but I would like to continue to take on challenges in my daily work. I believe that the environment in which I can take on the challenges of projects in various phases is only possible at the Chemical & Biological Technology Labs, which handles everything from initial development products to commercial products in one place.

• Q4What is the appeal of working at Astellas?

  I am attracted to a work environment where I can take on a variety of challenges and work easily.

  We feel that this is an attractive environment in which to work. First of all, there is an environment where you can concentrate on your experiments. We have a wide variety of equipment, reagents, and analytical instruments for the experiments we want to conduct. We can work in teams of several people to challenge new trial, and we receive support in various ways, such as the introduction of necessary equipment. In addition, there is a culture of easy communication with people in the workplace. Regardless of the year, we are able to help each other by sharing our opinions and suggestions and receiving advice on experiments. New ideas are often born out of chit-chat. It is a good work environment in terms of work-life balance. FF Day, in which finish work earlier on Fridays, has been introduced, and paid vacations are easy to take, so employees can refresh themselves regularly. Many employees work according to their life events, such as male employees taking maternity leave.
  Another major attraction of this company is that employee growth is generously supported. Rotational training, in which employees visit related departments, allows them to deepen their understanding of their work and how their own department's work is related to the processes before and after them. When I participated in training for a department that handles biopharmaceuticals in the same laboratory, it was an opportunity to deepen my understanding of biopharmaceuticals and reconsider the characteristics of small molecule pharmaceuticals. In particular, we have a significant relationship with the manufacturing plant, which synthesizes drug substrates using the manufacturing process we created, allowing us to experience the manufacturing site over a six-month period. The scale-up from the laboratory to the manufacturing site is not simply a difference in size. The perspectives that can be learned from the manufacturing site are also important for future process development, and I find it attractive to be able to experience this as training. In addition, we have other systems in place to support self-improvement, such as participation in domestic and international academic conferences and support for degree acquisition. The fact that there are many people challenging themselves to achieve their goals is a good stimulus, and I think it is an environment where we can grow together.

A day in the life of Honoka Teraji

8:30	Arrive at office, check email and daily schedule
8:30 to 12:00	Experiment : Prepare and track reactions, collect experiments from the previous day
12:00 to 13:00	Lunch at the company cafeteria. You can have a delicious lunch with many varieties at a reasonable price.
13:00 to 15:00	Sometimes there are meetings with the team or research contractors.
15:00 to 15:30	Take a break for discussion at the company café. There is a daily menu, which is fun.
15:30 to 18:00	Summary and discussion of experiments and confirmation of tomorrow's schedule.
18:00	Leave the office. Sometimes we go out to dinner with our peers.

• Q1What is your current job description?

  Development of the Cell Culture Process for Antibody Pharmaceuticals.

  I am working on the development of cell culture processes for the production of antibody pharmaceuticals. Pharmaceutical companies have a responsibility to consistently deliver high-quality and safe products to the many patients in need. To achieve this, it is necessary to develop a process that not only verifies the effectiveness and safety in clinical trials but also produces and supplies high-quality products. In the case of antibody pharmaceuticals, it is necessary to develop a cell culture process that maximizes the productivity of the cell line producing the antibodies and demonstrates stable quality.
  Furthermore, the developed process must not only be demonstrable at the laboratory scale but also ensure equivalent performance when scaled up to bioreactors hundreds to thousands of times larger than the laboratory scale. Therefore, we are concurrently working on various technological developments in parallel with our process development tasks, utilizing them to enhance the development of better processes and their scale-up evaluations.
  In addition, process development work is sometimes carried out in collaboration with other companies. We discuss the planning of experiments and interpretation of results needed for process development while progressing together. As we often collaborate with overseas companies, there are opportunities to engage in global work, which requires proficiency in English for effective communication.

• Q2When do you find work interesting or difficult?

  The Fascination of Encountering "New Things" and the Challenge of Solving Them

  What I find interesting about this job is that I encounter a lot of "new things." In the field of biopharmaceuticals, there are many "new things" such as the process development for new antibody molecules or New Modalities, advancements in technology, the introduction of new equipment, and the absorption of new knowledge. However, for every encounter with something "new things," an equal number of "challenges" arise. "Challenges" like developing the suitable processes for new molecules/New Modalities and establishing the operational systems to ensure that newly introduced equipment is accessible to everyone, and more, also emerge in abundance, and more, also emerge in abundance. It can be difficult to solve these "challenges" on my own, but through discussions and verifications with the team, we can lead to new discoveries and find solutions, which in turn adds to the excitement. I consider myself fortunate to be able to work at Astellas, where such an environment exists, as I have a curious and inquisitive nature.

• Q3In your work, what challenges would you like to take on in the future?

  Reliable and Swift Process Development and Challenging Technological Advancements

  In pharmaceutical process development, I understand that ensuring reliability in the work is crucial, as it is necessary to develop a process for producing active pharmaceutical ingredients stably without causing delays to the schedule. In recent years, Astellas has seen an increase in achievements in process development for antibody pharmaceuticals, and a platform for process development is beginning to take shape. However, many specialized antibodies like bispecific antibodies come into play on the development stage. It becomes necessary to optimize the process for each molecule. Therefore, I aim to leverage scientific knowledge and experience for any type of molecule, in order to swiftly develop a reliable process.
  Additionally, new technologies in the field of biopharmaceuticals are advancing at an astounding pace. To avoid falling behind in the industry, it's crucial to constantly monitor new technologies, evaluate their potential usefulness for our company early on, and take in those valuable technologies. While implementing such technologies may take time, I consider it a highly rewarding endeavor, as it could potentially elevate our company's technological capabilities. I'm eager to take on these challenges actively.

• Q4What is the appeal of working at Astellas?

  Open and Transparent Work Culture

  Even as a young professional, I feel comfortable expressing my opinions in this open and communicative work environment. As a result, each individual is able to showcase their unique personalities and expertise while collaborating effectively on tasks. In meetings, there is active exchange of ideas, regardless of whether someone is a young professional or a seasoned veteran.
  
  Furthermore, I perceive that young professionals are provided with numerous opportunities for growth, such as participation in conferences. While the shift to online participation has increased due to the impact of COVID-19, there are still opportunities to attend international conferences locally, allowing us to stay updated with the cutting-edge developments in the industry. If there is an interest in new technologies from other companies, regardless of one's seniority, arranging meetings or attending seminars is possible, facilitating information gathering.
  
  Moreover, the company as a whole is dedicated to promoting work-life balance, including both work and parenting. In my department, it is relatively easy to take maternity or paternity leave, and many individuals, regardless of gender, have taken advantage of this opportunity. I myself took paternity leave when my first child was born.

A day in the life of Masaru Shimojo

6:00	Wake up. Get ready with the family.
7:30 to 8:30	Commute to work. Review the day's schedule.
8:30 to 9:15	Daily team meeting. Review progress and coordinate tasks.
9:15 to 12:00	Conduct experiments. Collaborate with the team.
12:00 to 13:00	Lunch in the company cafeteria. Take a break to prepare for the afternoon.
13:00 to 16:00	Meetings. Share experiment results and engage in discussions as needed.
16:00 to 17:45	Desk work. Plan experiments, prepare reports, conduct literature research, etc.
17:45	Leave work. Pick up my daughter from daycare, and return home.

• Q1What is your current job description?

  We research to find the optimal drug delivery system (DDS) for "drug seeds" having pharmacological effects for enhancing the delivering value for patients.

  “Drug seeds” (active ingredients or drug substances) include various modalities such as small molecules, antibodies, nucleic acids, and cells etc. Pharmaceutical research is converting them into “drug products” that can be administered to patients. In the research area, DDS is a technology to control movement of the drug substances in the body after administration. To improve drug efficacy, reduce side effects, and/or improve patients convenience, our challenge is to create drug products for delivery of the optimal amount of drug substances for the appropriate time to the best sites in the body where the drugs perform their efficacy.
  
  I’m working at DDS Laboratory. We investigate and select the optimal DDS technologies for each modality and issues, when it’s difficult to develop the "drug seeds" to drug products due to their insufficient efficacy and/or extensive side effects etc. If there is no suitable technology, we investigate and create a new pharmaceutical technologies, i.e., a novel invention. We hear voices and needs of patients and medical professionals from other departments members in such as sales reps, and we confirm what kind of formulation is required.
  We prepare and evaluate prototype DDS formulations in vitro and in vivo to confirm their performance. These evaluations are conducted by ourselves, and sometimes by research division members with specific techniques. After execution of cycles of the studies to improve formulations performance, we file formulation patents application if the concept of DDS technology is confirmed.
  To realize the prototype DDS formulation into “drug products” having higher quality, stable manufacturing, we relay the baton to formulation design researchers. They investigate optimization of formulation compositions, such as types and amounts of excipients, and manufacture investigational drugs for clinical trials. To establish stable and efficient manufacturing process for the high-quality “drug products” with low cost, researchers at Process Technology Laboratory optimize the process, and transfer the technology to global manufacturing sites. To protects the quality of “drug products” during long-term storage and transportation, researchers at Packaging and Devices Laboratory design the optimal packaging which is easy to use for patients and medical professionals. In recent years, we also develop administration devices for easy dosing and medical apps (Software as Medical Device).
  
  In addition to experiments and collaboration with various experts, search and understanding of the world's cutting-edge DDS technologies are also important aspects for us. Reading the latest and cutting-edge papers and patents enables us to select the most suitable DDS technology for each modality and issue and promote development of drug products.

• Q2When do you find work interesting or difficult?

  Research often does not progress as expected, but I feel pleasure of being able to quickly deliver high value to patients, and scientific interesting when we obtain experimental data which contribute to projects promotion even a little through trial and error with team members.
  
  In some projects, we discuss with overseas members in English. Previously, when I proposed a future plan based on our data, miscommunication prevented smooth discussion and obtaining consensus. Therefore, I obtained additional data, improved phrasing and expression, and finally, I could get consensus on our idea and felt a sense of accomplishment.

• Q3In your work, what challenges would you like to take on in the future?

  I would like to try formulation development for various “drug seeds” and deliver the value to patients.

  Issues to be solved and the suitable formulations depend on the modality of “drug seeds''. Content of investigation and collaboration partners also differ between drug discovery projects in early stage and development of additional dosage forms for launched products as LCM (life cycle management). In order to make drug products of the various “drug seeds” launched, I intend to continue to challenge technology search and formulation preparation, accumulate knowledge and experience, and would like to contribute to “value for patients'' as a formulation researcher.
  
  Moreover, expertise in many fields is essential to promote projects. For commercialization of products, it’s extremely important to communicate with a variety of key stakeholders having expertise such as pharmacology, synthesis, pharmacokinetics, safety, regulation, stability, equipment etc.. Mutual understanding is also a key for success in collaboration with academia and startups.
  I would like to learn more knowledge from my seniors, expand my views as a pharmaceutical scientist, and continue to take on challenges together with colleague teams.

• Q4What is the appeal of working at Astellas?

  We can feel our own growth while receiving cooperation and support from many colleague.

  As one of attractive points in working with Astellas, we, young researchers, can be assigned to a responsible researcher of a project, receive generous support from our senior colleagues, and grow ourselves through the projects. In organizational culture of Astellas, employees share own thoughts and ideas and respect each other, regardless of age or department.
  In my second year working in Astellas, I was assigned as a responsible researcher of a project for the first time, and I didn't know what/how to proceed with the project and how to collaborate with colleague etc. At that time, I received many advice and suggestions from my seniors and team members, and tried candidate ways by myself, and gradually I was able to proceed the project more smoothly. Even now, I sometimes consult with my seniors when I don’t have confidence in selection of options. Senior colleague always take time to listen to my opinions and give me thoughtful advice even in their busy time. I believe, another attractive point in working with Astellas is that we can respect many seniors not only as a researcher, but also as a person.
  
  Additionally, Astellas has many programs for employee’s growth. For example, young colleague, called mentors, teach the basic social manners and company rules to new commers (one and a half years after joining Astellas). To encourage growth as scientists, there are several supporting systems such as obtaining Ph.D. degrees, participation in academic conferences, and visiting scholars at foreign academia.
  I will continue to grow myself day by day so that I can become a reliable senior for my juniors.

An example of my daily schedule

8:30 to 9:00	Come to the office. Check e-mails and confirm my schedule for the day.
9:00 to 10:00	Discuss experimental data with team members to determine our future plan. Sometimes the discussions are in English.
10:00 to 12:00	Do experiments. Check e-mails during breaks.
12:00 to 13:00	Lunch with department members at the cafeteria in the research center. Relax and enjoy playing table tennis with everyone.
13:00 to 14:30	Do experiments. Check e-mails during breaks.
14:30 to 16:30	Read scientific papers.
16:30 to 17:30	Summarize experimental data and prepare presentation materials for meetings.
17:30 to 18:00	Check e-mails and schedule for the next day, and then I go back home. (Time to go home is different depending on the day, and sometimes I go home earlier. Since business hours is 8:30-15:45 on every Friday, I enjoy playing tennis with my colleagues at the company tennis court around 16:00.)

* Affiliation at the time of posting.

• Q1What is your current job?

  In order to deliver highly functional, high-quality drugs to patients as quickly and stably as possible, I am engaged in the development of test methods and research on the physico-chemical properties of drug products.

  Proper design and manufacturing of drugs and assurance of their quality are essential to deliver safe and reliable drugs to patients. In the Analytical Research Labs., we mainly develop test methods to evaluate the quality of drugs (drug substances and drug products) and conduct research to understand their physico-chemical properties.
  I am currently in charge of the development of test methods and research on the physico-chemical properties of small molecule drug products (formulated products for administration to patients) under development.
  In the test method development, we control the quality of drug products by setting test procedures and acceptance criteria from the development stage when clinical trials are initiated. As the development progresses, the level of control is increased to achieve higher quality in terms of efficacy, safety, and stable supply. A drug product is not a single component of the drug substance (the active ingredient of a drug), but a mixture including excipients. Drug product-specific impurities resulting from reactions with excipients and packaging can be present in the drug product. Furthermore, a single drug substance can be used to design drug products with various contents, dosage forms, and formulations. Therefore, when developing a test method for a drug product, sample preparation methods and analytical conditions must be optimized according to the properties of the drug product, and a wide range of test items must be set.
  In physico-chemical properties research, we evaluate the functionality of formulations, such as improvement in stability and dissolution by excipients, and investigate the causes of quality issues. The information obtained from the physico-chemical properties research is shared with members responsible for formulation design and used to develop and improve formulations and manufacturing processes, thereby contributing to Astellas’s entire process of creating drug product from the quality aspect.
  In addition, I prepare documents for clinical trial application in various countries, transfer test method technology and outsource stability tests to analytical sites inside and outside the company, and conduct basic research for understanding drug product properties and exploring new technologies.

• Q2When do you find your work interesting or difficult?

  I find it interesting to come into contact with a wide variety of knowledge and technologies, and to utilize the skills and know-how I have acquired to move forward with my work.

  For the development of a single drug product, members with various backgrounds, including synthesis and analysis of drug substances, formulation and process design, work together. Furthermore, a wide range of technologies are used. In order to correctly understand and evaluate the quality of a drug product, not only knowledge of the physico-chemical properties analysis of the drug product and instrumental analysis techniques, but also knowledge in other specialized areas is necessary. Since joining the company, I have been given opportunities to develop various test methods, conduct research on physico-chemical properties, and attend meetings and training sessions with members from other specialized fields. Through these opportunities I feel that my knowledge and skills are expanding every day. I feel a sense of accomplishment when I am able to develop and present optimal analytical methods in accordance with the characteristics of the analyte based on my accumulated knowledge and experience.
  In some cases, problems with test methods and analysis, such as a lack of reproducibility or observation of outliers, could occur. It is sometimes difficult to solve the problems because the root cause could not be immediately identified. Even in such situations, I find it interesting to gain new insights through discussions with my seniors, information gathering from other departments, repeated experiments, and trial-and-error. When we reach a solution, I feel a great sense of accomplishment, and at the same time, I feel a sense of growth, which is very rewarding.
  In order to work efficiently and effectively, knowledge of pharmaceutical regulations, knowledge of statistics and data science for analysis, and an understanding of the needs of analytical sites for technology transfer and outsourcing are also required. I feel that I have a lot to learn in my research life, and I am motivated every day by the fact that every single task I accomplish with the know-how I have gained is connected to "delivering drugs to patients".

• Q3What is something you would like to challenge yourself in the future at work?

  I would like to acquire a wide range of expertise centered on physico-chemical properties analysis, and to be able to lead the project in cooperation with people who are active in other fields.

  The work of the Analytical Research Labs. involves various processes from the development stage to post-launch. Currently, I am involved in the project of small molecule solid drug product in the early stages of development. In future, I would like to enhance my expertise in physico-chemical property analysis while gaining experience by challenging myself at various stages and analytical target. Like my seniors, I would like to be able to proactively lead the projects and contribute to the other departments from the viewpoint of physico-chemical property analysis.
  In addition to enhancing my expertise, I would like to take on challenges of introducing new technologies and proposing new solutions by expanding my knowledge and skills in other related fields and refining my imagination, creativity, and ability to think critically. I would also like to deepen my understanding of the work in different fields and contribute to promoting effective collaboration that takes advantage of each other's strengths.
  Furthermore, I am currently actively involved in joint research with other research institutions and participating in academic conferences, which gives me many opportunities to look outside the company. My dream is to continue to participate not only in internal but also external activities and eventually become a researcher who can contribute to the pharmaceutical industry as a whole through physico-chemical property analysis.

• Q4What attracts you to working at Astellas?

  I am attracted to the environment where I can grow and take on challenges.

  Astellas has a culture that respects diversity and individual personality, and there are people with various backgrounds, specialties, and careers inside and outside the research laboratories. Moreover, as a global pharmaceutical company, Astellas has many relationships with people from overseas. In e-mails and meetings, we have lively discussions from various perspectives. I feel that I am inspired and broadening my perspective in the global stage. Another attractive aspect is the opportunity for employees to share and enhance each other's knowledge, experience, and strengths through work-related study sessions and debriefing sessions. Furthermore, the company values and respects the opinions of young employees. We are blessed with an environment where young employees are entrusted with important work and encouraged to actively take on new challenges.
  In the Analytical Reserach Labs, we have working team (WT) activities to conduct basic research for a deeper understanding of physico-chemical properties and to develop technologies to solve common issues among new drug development projects. I have participated in several WT activities. One of the attractive points of WT activities is that there are opportunities for growth as a researcher, where we can try the development and acquisition of new technologies based on our own ideas without being bound by precedents.

A Day in the work of Hitomi Okada

6:30	Wake up. It takes about 15 minutes to walk from home to the office.
8:00-8:30	Arrive at work. Check e-mails and the daily schedule.
8:30-9:00	Analyze the results of the previous day's experiments.
10:00-12:00	Conduct experiments. In my spare time, check e-mails and prepare documents (most of the documents are prepared in English for the global market).
12:30-13:30	Have lunch at the company cafeteria.
13:30-14:00	Discuss experiment details and documentation policies with team members.
14:00-15:00	Attend meetings with other departments (some meetings are with overseas sites).
15:00-17:00	Continue experiments and record experiment details in the electronic laboratory notebook.
17:00-18:30	Prepare reports and meeting materials.
18:30	Confirm the schedule for the next day. Leave the office (leaving time may vary depending on the day).

• Q1What is your current work?

  I am engaged in the development of analytical methods for evaluating the quality of drugs and research to understand their physical properties.

  I am mainly engaged in the development of analytical methods and research on physical properties related to the evaluation of biological activity of antibody drugs under development. I am developing analytical methods to evaluate the quality of developed antibodies based on the mechanism of action, such as the binding between antibodies and antigens, and the signal transduction reaction associated with the binding. We use various methods such as ELISA, flow cytometry, and reporter gene assays. We are working on understanding the mechanism of action and examining the test conditions in order to develop analytical methods that can correctly and stably evaluate the activity. The analytical methods we develop are used as part of quality testing to ensure that the manufactured drug product meets the desired quality.
  In addition, I conduct research to understand the properties and characteristics of developed antibodies as part of our physical properties research. Analysis of the structure of developed antibodies, stress-induced structural changes, and the correlation between such structural changes and biological activity are analyzed to gain a better understanding of developed antibodies, to select important parameters for quality control, and to provide justifications to pharmaceutical regulatory authorities. The research is carried out in conjunction with structural evaluation information obtained by HPLC and mass spectrometry (MS) at the same laboratory, so a wide range of knowledge is required. I think that elucidating physical properties based on various data is a very interesting part of the research. Of course, collaboration with other laboratories is also indispensable in understanding physical properties. The data on the physical properties of developed products obtained from the manufacturing process research conducted by the Chemical & Biological Technology Research Laboratory and the formulation research conducted by the Pharmaceutical Research & Technology Laboratories is valuable information that cannot be obtained by the Analytical Research Labs. alone. I analyze samples produced in the research process at each laboratory to obtain data on physical properties and provide the analysis results for each laboratory to promote research at each laboratory from the viewpoint of physical properties.

• Q2When do you find your work interesting or challenging?

  The process of developing robust analytical methods is very difficult and interesting.

  The various analytical methods we develop at our laboratory are used for long-lasting quality testing at manufacturing plants in Japan and overseas. Therefore, they must be robust analytical methods that can evaluate the quality of pharmaceuticals at a certain level regardless of the testing site or the analyst. When developing an analytical method, we investigate factors that may affect robustness, such as the source and lot-to-lot difference of reagents and the manufacturer and model number of analytical equipment, in addition to the operating procedures, analysts, and testing sites, to optimize the testing conditions. In particular, it is very difficult to obtain stable data for cell-based test methods because the analytical results may vary due to changes in cell conditions caused by slight changes in culture conditions or differences in passage number. For this reason, I feel a truly great sense of accomplishment when I understand the characteristics of an analytical method and complete a robust test method after much trial and error.
  Another attractive point is that the work of the Analytical Research Labs. is very broad. In addition to the microplate reader and flow cytometer that I am currently using, there are HPLC, GC (and other chromatographic instruments), MS, NMR, DSC, X-ray equipment, and etc. When I was a student, I mainly conducted bioactivity evaluations using cells, but since joining the company, I have also been conducting analytical method development using HPLC, MS and other instruments that I have never used before, so I am learning new fields through work.
  In addition to experimental work, we also handle regulatory affairs application and transfer analytical method technology to domestic and overseas testing sites, so I find it very interesting and challenging to work at the Analytical Research Labs., where I am constantly learning new knowledge and technologies. By learning new fields, I am able to gain a deeper understanding of drug development, which always keeps my days fresh and enjoyable. Of course, when learning a new field, I can take on the challenge without worry as my senior experts provide detailed guidance.

• Q3What would you like to challenge yourself in the future at work?

  As an analytical specialist, I would like to be able to lead development projects.

  As mentioned above, the work of the Analytical Research Labs. requires a wide range of skills, including analytical method development, physical properties research and pharmaceutical applications. Therefore, my daily work is a series of challenges. In the future, I would like to acquire a wide range of know-how in various fields by accumulating these daily experiences, and to be able to lead projects as an expert in analysis. In addition, as a project leader, I would like to contribute to the stable supply of safe and trusted drugs by collaborating with various departments within our company and with manufacturing and testing companies in Japan and overseas. Although I am still a novice in every field, I feel that I am growing step by step as I gradually gain experience in developing various types of test methods, acquiring data on physical properties, and preparing regulatory applications. I would like to continue to take on new challenges and continue to grow.

• Q4What is the attraction of working at Astellas?

  It is the excellent training system and growth support for employees.

  We have a mentor system in which you work together with senior employees for the first year and a half after joining our company. They are always available for consultation, so you can work with peace of mind. Of course, other than the mentors, all senior employees are also kind enough to teach you. During discussions, they are always willing to treat each other as equals as researchers.
  Astellas is a "treasure house" of experts in various fields, so to speak, and I feel that it is an environment in which it is easy to take on challenges in new fields.
  The Analytical Research Labs. is eager to acquire new technologies and research methods, and even young employees are given opportunities to actively take on new challenges. Since my third year with the company, I have joined a new technology development team on a voluntary basis, in addition to my work on development projects, and am working on the establishment of a test method to evaluate immunogenicity which is related to the safety of drugs.
  There are also various other opportunities for businessperson to obtain doctoral degrees, study abroad or be posted overseas. The will to grow with the company as well as yourself is respected, and your supervisor actively encourages you to do so.
  I feel that Analytical Research Labs. has a particularly good support system. The phrase that left the greatest impression on me during my job search was, "Analytical Research Labs. is a department that values human resources."In fact, few people have the experience in the development of high-precision analytical methods, extensive evaluation of physical properties and pharmaceutical application work that is performed at Analytical Research Labs. during their university days. For this reason, the department as a whole focuses on "nurturing employees," which I feel leads to the enhancement of training programs and growth support.
  
  I am also attracted to the fact that I can grow on a global stage. Astellas has R&D and production sites in Japan and overseas. The projects I am currently in charge of are all global development products, and I sometimes have meetings with overseas representatives in English. In order to obtain regulatory approval in various countries, we file regulatory applications in accordance with country-specific regulations. I feel that the appeal of working at Astellas is that I can broaden my horizons through this kind of work in the global arena.

A Day in the work of Shintaro Yamane

7:30	Wake up. Commute to work takes about 15 minutes by car.
8:30 - 9:00	Arrive at work. Check email and daily schedule.
9:00-10:00	Weekly bioactivity evaluation team meeting (members who mainly conduct bioactivity evaluation gather to report on the status of their experiments and discuss what other members are studying).
10:00-12:00	Experiment (cell passaging, start of cell tests).
12:00-13:00	Lunch at the cafeteria in the laboratory. On a fine day, I take a walk around the laboratory with my colleagues to refresh myself.
13:00-15:00	Experiment (measurement with FCM), analysis of experimental results.
15:00-16:00	Discussion with senior employees about the results of experiments and future studies.
16:00-17:00	Monthly joint project meeting with other laboratories (sharing the analysis results of research samples from other laboratories and discussing the results and future study policies).
17:00-18:00	Preparation of progress report materials and reports on experimental details. Occasionally, literature research is also conducted.
18:00-18:30	Confirm the next day's schedule and leave the office (leaving time may vary depending on the day).

• Q1What is your current job description?

  I am currently involved in a wide range of tasks from both engineering and technical development perspectives.

  In the engineering field, I am primarily responsible for facility renovations and equipment installation projects for the development of manufacturing platforms for cell therapy products. I have been organizing requirements based on the flow of people and materials during manufacturing, creating equipment lists, considering equipment layouts, and designing power and piping locations, all while collaborating with internal and external stakeholders. We have now entered the phase of determining building specifications, and we have received drawings reflecting the discussions so far from our partner companies, and we are making final adjustments in preparation for construction.
  
  On the other hand, in the technical development area, we are introducing an autonomous patrol robot to automate inspections of the machinery room, and we are adjusting towards implementation. By automating routine inspection tasks and environmental measurements, we aim to improve work efficiency and reduce human error. Currently, we are designing the inspection flow for automatic meter reading, as well as verifying the effectiveness of temperature anomaly detection using thermal cameras, which is difficult to achieve through visual inspections by humans. In our engineering, we are not directly involved in the design and development of robots themselves, but we are advancing the construction of systems optimized for the on-site environment by flexibly combining commercially available equipment and existing technologies.

• Q2When do you find work interesting or difficult?

  While I find great interest in seeing the results of the discussions we have had with both internal and external parties take shape, I also feel the challenge of needing to appropriately translate and organize information among stakeholders.

  In my work, I collaborate with many stakeholders, including external construction companies, various equipment manufacturers, and internal departments such as research, procurement, and manufacturing. Amid the diverse considerations, when differences in opinion arise or when challenges become difficult to realize, adjustments are necessary to find the optimal solution, and I sometimes feel the difficulty in that process. On the other hand, I find great stimulation and interest in being exposed to others' opinions and expertise, gaining new perspectives. When we have thorough discussions with various individuals, complete the equipment installation, and proceed with manufacturing and research as planned, I strongly feel a sense of accomplishment and it's the best part of this work.

• Q3In your work, what challenges would you like to take on in the future?

  What I want to challenge myself with in the future is participating in the establishment project of a facility for pharmaceutical research. Currently, I am involved in the project for setting up a manufacturing site for cell therapy products, and through this experience, I have strongly realized the importance of not only knowledge related to manufacturing management and quality control of pharmaceuticals but also understanding the research and development process leading to manufacturing.

  Moving forward, I aim to deepen my understanding of the analysis processes necessary to ensure quality, in addition to the pharmaceutical manufacturing processes, and to gain a broad range of experience and knowledge as an engineer who can oversee the entire flow from research to manufacturing. Furthermore, there is a growing potential for automation in the field of pharmaceutical research, and I hope to contribute to delivering medications to patients more quickly through the establishment of efficient research facilities. I feel that my environment of this group is well-equipped for taking on diverse challenges, allowing for personal growth while contributing to society.

• Q4What is the appeal of working at Astellas?

  I find great appeal in being able to contribute to patients' health through the establishment of pharmaceutical research and manufacturing facilities, as well as the numerous opportunities provided for young professionals to thrive.

  In our engineering, we may not have many opportunities to interact directly with patients through our work, but when I consider that the facility setups and new technology developments we undertake ultimately lead to delivering medications to patients, I feel a strong sense of social contribution.
  
  Additionally, in the facility renovation and equipment installation project I am currently involved in, I have been entrusted with compiling the process requirements that serve as the project's guidelines. Furthermore, in the introduction of the autonomous patrol robot, I am responsible for important considerations towards implementation, with support from my senior colleagues, and I feel my growth in various situations.

A day in the life of Tamaki Kawano

6:30	Wake up! I’m transferring trains from my home to my office.
8:30~9:00	Going to work. Check your email, check the task list you organized the day before, and add it.
9:00~10:00	I compile the necessary materials for internal and external meetings.
10:00~12:00	Create a flow for the automated patrol robot and test run it in the machine room. Summarize the issues that arise during commissioning and provide feedback to the manufacturer.
12:00~13:00	Lunch
13:00~15:30	We will participate in meetings with external partner companies for facility renovation and proceed with specification reviews.
15:30~17:30	We discuss with the internal department in charge of feedback on the specifications decided in meetings with partner companies and confirmation matters with partner companies.
17:30~18:00	Check your email and organize your task list for the next day.
18:00	Returning home (leaving time depends on workload.) On Fridays, there is a system called Family Friday, and I sometimes go home around 15:30~17:00.

* Affiliation at the time of posting.

• Q1What is your current job description?

  In my current role, my primary focus is on enhancing the quality and efficiency of drug manufacturing by utilizing the latest technologies such as AI, XR, RFID, biometrics, and robotics.

  Since joining the company, I've been primarily involved in technical development, collaborating with various departments in the pharmaceutical technology sector to explore the feasibility of implementing these technologies in drug manufacturing processes. This encompasses a wide range of activities beyond pharmaceutical production itself, including maintenance, technology transfer, inventory management, access control, and laboratory research.
  The pharmaceutical industry is often said to lag behind other industries in the adoption of new technologies due to the high demand for safety in providing products that involve human lives, and the strict rules that must be adhered to in drug development. Within such constraints, there is a strong demand for agility and flexibility to quickly verify the effectiveness of new technologies and proceed with their implementation to the extent possible.
  Currently, one of my key projects involves validation of AI predictive maintenance system.This system utilizes AI to detect abnormalities in equipment in advance, using data collected from the equipment to conduct machine learning and verify whether past abnormalities could have been predicted. We're working on this with a focus on eliminating sudden equipment failures, contributing to the VALUE for patients by ensuring a stable supply of medications. In addition, we regularly participate in exhibitions to collect new technical information.

• Q2When do you find work interesting or difficult?

  I find it both interesting and challenging because I have to collaborate with a diverse array of people across various departments, both internally and externally, and because of the significant flexibility in my role.

  Especially when I meet with manufacturers who own new technologies, I often find it challenging to realize that assumptions one party makes might not align with the other's.
  Moreover, technology development involves a lot of flexibility, requiring individuals to set their own criteria for verification and final goals. I find it interesting to have some degree of discretion in approaching tasks, but at the same time, I feel the difficulty in setting goals during the early stages of projects is crucial.

• Q3In your work, what challenges would you like to take on in the future?

  What I would like to try in the future is participating in construction projects.

  Since joining the company, I have mainly been engaged in technology development work, partly because it was my wish.As for engineering projects, I have only been in charge of basic design work for equipment introduction and renovation projects that do not involve development elements, and I have no experience in actually building buildings or conducting renovation work. Therefore, I would like to gain experience in engineering work at the construction stage in the future.This is because as we proceed with technology development work, engineering knowledge and experience are often required, and I feel that experience in both, rather than one or the other, is necessary. In particular, the launch of a new building can be properly called "manufacturing" because it visibly creates something from nothing. If I have the opportunity, I would like to participate in the project to launch the new building.

• Q4What is the appeal of working at Astellas?

  In my current department, younger employees are often given significant responsibilities early on. In my second year, I took the lead on renovation planning and basic design for a section of our investigational drug building. By my third year, I was managing multiple projects related to new technology development, collaborating across departments. Although I had senior colleagues and supervisors for guidance, I primarily managed these projects independently, handling everything from scheduling to implementation. This allowed me to gain diverse experiences and feel a strong sense of personal growth. Another aspect of Astellas that I find appealing is its culture of embracing challenges company-wide

A day in the life of Masaki Taneo

7:00	Wake up.Commute by car takes 30 minutes.
8:30 to 9:00	Arrive at the office. Check emails and review the schedule for the day.
9:00 to 10:00	Meeting with internal counterparts to discuss ongoing technical development projects.
10:00 to 12:00	Reviewing verification items and preparing documents for technical development.
12:00 to 13:00	Lunch break.
13:00 to 15:00	Meetings with external manufacturers and agents.
15:00 to 16:00	Internal meetings.
16:00 to 18:30	Document preparation.
18:30 to 19:00	Check emails and organize schedule for the next day.
19:00	Leave the office (Note: Departure time may vary depending on workload. On Fridays, there is a Family Friday program, so departure may be around 4:00 PM).

* Affiliation at the time of posting.

• Q1What is your current job description?

  In the Technical Development Section, to which I belong, we are engaged in the stable supply of antibody drugs and the examination and improvement of manufacturing procedures at the actual production scale. Currently, I am handling two products: an intermediate product of PADCEV, which is designated as a breakthrough therapy by the FDA, and zolvetuximab, which is in the Phase III clinical trial stage. In my first year with the company, there was an FDA inspection of PADCEV. I was able to experience firsthand the importance of social responsibility and the patients that await us beyond our day-to-day work. By my third year, I was involved in a variety of tasks, including the start-up of a new Astellas manufacturing facility, the introduction of zolvetuximab into the new facility, and the scale-up of PADCEV production as it continued to increase. Now, in my fourth year with the company, I have increased my skills and knowledge necessary for antibody production, and I feel that I am contributing to the stable production of high-quality drugs to deliver them to patients around the world who are waiting for them

• Q2When do you find work interesting or difficult?

  I feel fun and a sense of accomplishment when I face a difficult problem and clear it with a method that has no track record so far. The global COVID-19 epidemic has dramatically changed the environment surrounding pharmaceutical manufacturing, creating many challenges. As a result of tackling one of the issues, we adopted a new policy and solved the issue caused by COVID-19. On top of that, we were able to introduce the best system with lower costs than before. In the process of solving problems, it is essential to collaborate not only with our own department, but also with other departments and outside the company that we usually have little involvement with. However, I still vividly remember the moment when the initiative took shape, I was overwhelmed with joy.

• Q3In your work, what challenges would you like to take on in the future?

  Based on the skills and knowledge I have acquired through the stable production of PADCEV intermediates and the development of commercial manufacturing processes for zolbetuximab drug substance, I will develop and strengthen commercial manufacturing processes for new modalities such as cell therapy. I would like to work as a biopharmaceutical professional.

• Q4What attracted you to work at Astellas?

  The great attraction of working at Astellas is the people. Delivering a single drug to patients involves more people than you might imagine, including research, development, manufacturing, and sales departments. In order to deliver drugs to patients more quickly, collaboration with various people is essential. I empathized with the atmosphere that the senior who was in charge of the company information session introduced the workplace lively, and I wanted to work at Astellas. When I actually joined the company, that intuition was correct. Of course, I had the cooperation of everyone in other departments when I was solving the aforementioned issues, but I am also very grateful to my boss, who encouraged me to grow while maintaining an appropriate sense of distance and correcting my trajectory as necessary. I'm here.

A day in the life of Taku Shibuya

8:00-9:00	Radio gymnastics. At the morning meeting, we share the flow of work for the day, the division of roles, and the work status up to the previous day.
9:00-12:30	manufacturing work.
12:30-13:30	Lunch in a buffet style dining room. There is a seasonal local menu!
13:30-15:00	Continue manufacturing work. Clean up after work.
15:00-16:30	desk work. Confirmation of records used in manufacturing and preparation of documents such as procedure manuals.
16:30-17:00	Prepare documents and equipment to be used in the next day's manufacturing work, check the work flow, and go home. * Affiliation at the time of posting.

* Affiliation at the time of posting.

• Q1Could you tell us about your current role?

  I am engaged in process validation, improvement, and manufacturing of clinical trial drug substances to ensure a stable supply of high-quality active pharmaceutical ingredients (APIs).

  The Takahagi Technology Center is Astellas’ only manufacturing site in Japan specializing in chemically synthesized APIs. Through chemical synthesis, we play a key role in stably supplying drug substances that serve as the raw materials for pharmaceuticals, ensuring that safe and reliable medicines reach patients around the world.
  Within the Manufacturing Technology 1, we collaborate closely with the API Research Laboratories and other research divisions to develop and verify manufacturing processes using our pilot plant facilities. By manufacturing clinical trial APIs, we contribute to delivering new medicines to patients when they are needed most.
  In the early stages of drug development, information on chemical properties or biological activity is often limited, and unexpected phenomena may arise during the actual manufacturing process. To prevent such issues, we conduct multifaceted verifications—not only from the perspective of chemical synthesis, but also chemical and mechanical engineering—taking into account equipment conditions and operational feasibility. We then share the knowledge gained through experiments and manufacturing activities with research and production teams to promote more efficient and reliable process development.
  As a result, we achieve improvements in environmental sustainability, operational safety, product quality, and cost reduction—all of which lead to the earlier and more stable delivery of new drugs to patients. Working with colleagues from diverse academic backgrounds such as chemistry, engineering, and pharmaceutical sciences also enables me to receive valuable insights from multiple perspectives, helping us build more optimized manufacturing processes.
  In this way, our work in the Manufacturing Technology 1 is deeply rewarding, as it allows us to apply a wide range of knowledge and skills to create significant value for patients around the world.

• Q2When do you find your work most interesting or challenging?

  When I can confirm in the manufacturing plant that the results of my process validation experiments have successfully solved an issue.

  I find it fascinating to formulate hypotheses, perform validation experiments, and implement improvements in quality and operational efficiency. In clinical API manufacturing, there are often limited data and few precedents for scale-up, so identifying critical operations and establishing effective countermeasures through preliminary studies is essential. When these efforts lead to greater process stability or efficiency, it gives me a strong sense of accomplishment.
  Another appealing aspect is that I can participate directly as an operator in the processes I have developed, experiencing firsthand the improvements at scales hundreds or thousands of times larger than in the laboratory. Although this comes with considerable responsibility, the moment I confirm that the process I designed works effectively in production and yields a high-quality API, I feel an immense sense of achievement.
  Of course, things do not always go as planned—that is part of the challenge—but I find great satisfaction in the process of trial and error that leads to the optimal solution.
  Clinical API manufacturing also involves collaboration with many departments, including research laboratories. Working with professionals from diverse technical backgrounds who share their expertise and cooperate toward solving problems is another major attraction of this role.

• Q3What do you want to challenge yourself with in the future?

  I aim to further enhance my expertise in API manufacturing based on chemical synthesis.

  In recent years, collaboration between research laboratories and manufacturing sites has become increasingly close. Even for those engaged in production, it is becoming more important to not only have a manufacturing perspective but also to understand research perspectives. By understanding the meaning and principles behind each process operation, we can design and construct more effective methods.
  I believe that the ideal professional in API manufacturing is someone who can optimize the overall process without compromising on any aspect—environment, safety, quality, delivery, or cost.
  To strengthen my abilities, I also consider it essential to acquire new technologies. By attending academic conferences and technical seminars, I hope to deepen my expertise, broaden my perspective, and continue to take on challenges that lead to the development of high-value manufacturing processes.

• Q4What do you find attractive about working at Astellas?

  Astellas provides an environment where we can proactively take on new challenges.

  Although the pharmaceutical industry and social needs are constantly evolving, Astellas’ mission—to continue delivering value to patients—remains unchanged.
  Astellas is committed to transforming scientific advances into value for patients by continuously pursuing the development of not only conventional small-molecule drugs but also innovative modalities such as PROTACs, ADCs, and gene therapies.
  At the Takahagi Technology center, we also challenge ourselves to apply our expertise in chemical synthesis to these new modalities. Being in an environment where I can contribute to such diverse areas of drug manufacturing is a source of great motivation and fulfillment for me.

A Day in My Work Life

7:20	Wake up (10-minute drive to work)
8:15~8:20	Check emails and schedule for the day
8:20~8:30	Morning exercise and team meeting
8:30~12:00	Experiment preparation and execution or manufacturing tasks, with documentation in between
12:00~13:00	Lunch at the cafeteria and break (I usually work out at the in-house gym)
13:00~16:30	Continue experiments or manufacturing, document preparation
16:30~17:00	Documentation or meetings (varies by day)
17:00~17:30	Clean-up and preparation for the next day
17:30	Leave work (On Fridays, we have an “FF Day” system allowing early leave at 15:30. I often spend the time visiting Tokyo or enjoying sports.)

* Affiliation at the time of posting.

• Q1Could you tell us about your current role?

  I conduct tests and evaluations, for example, in quality control tests and analytical method development related to clinical trial material, to scientifically support the quality of the product.

  I work in the Quality Control Section 1, where I am responsible for quality control activities related to clinical trial material.
  In addition to quality testing for clinical trial materials, I am involved in analytical method development for raw materials, cleaning verification tests, and analytical method validation. Through these activities, I help scientifically support and ensure the quality of the product. These processes are essential to maintaining stable quality from the clinical stage of drug development.
  
  Clinical trial materials often have product characteristics that are not yet fully understood, which makes unexpected issues more likely to occur for each product. Before joining Astellas, I assumed the work would be mostly routine. In reality, however, the job often requires flexible thinking and quick decision-making to handle unplanned situations.
  
  In addition to testing itself, maintaining the foundation of the entire quality control system is also a key mission of the Quality Control section. We are involved in managing computerized systems that ensure proper control of test data and in activities related to GMP training.
  If you join our department, you won’t just perform quality control tests—you’ll also be part of improving analytical methods and strengthening our quality management framework.
  
  Pharmaceutical quality is not something that can be added after manufacturing; it must be ensured from the very beginning through proper control. At our department, each test result directly affects product quality, so accuracy and integrity are essential. I approach my work with a strong sense of responsibility and professional pride.

• Q2When do you find your work most interesting or challenging?

  I feel the weight of responsibility, the mission to protect quality of the products, and a great sense of fulfillment when making decisions as part of Quality Control Section.

  One of the interesting aspects of this job is thinking about how to proceed with GMP procedures and test method considerations in cooperation with other departments without affecting the manufacturing schedule. It requires not only coordinating with my own department but also adjusting to the schedules of other departments, which calls for the ability to make decisions with the entire process in mind.
  
  In this process, I feel that I play an important role as an analyst by delivering quick and accurate results of the quality tests. When we work together with other departments to respond promptly and are able to ship on schedule, I feel a strong sense of accomplishment.
  
  In addition, decisions of the quality control section always have a significant impact on other departments and the entire project. When the Quality Control section determines that “the quality is acceptable,” it directly affects patient safety, making it a highly responsible role. In particular, when working with other departments, it is essential to understand each other’s perspectives and priorities while maintaining a firm commitment to quality without compromise. This “strictness” can be challenging, but at the same time, it is also a source of pride and a strong sense of responsibility as the last line of defense for product quality. Especially during training and discussions with other departments, I strongly realize that “quality control is not just about performing tests, but about supporting overall quality assurance.” This awareness gives me a strong sense of purpose in my work.

• Q3What do you want to challenge yourself with in the future?

  I would like to work on building systems and environments that can maintain and enhance a high level of quality control.

  Both people and systems form the foundation of quality control. No matter how excellent the testing methods or equipment are, without skilled personnel and a solid training framework, it’s impossible to sustain a high level of quality assurance. To further reduce human error and build a more efficient and robust quality control system, I would like to focus on improving our training structure in the future. Specifically, I want to make use of a system that visualizes the retention of knowledge and skills, ensuring that training has a measurable and lasting effectiveness of training. By promoting standardization and utilizing digital tools, my goal is to create a structure that guarantees consistent quality regardless of individual experience levels. I have already started building a post-training survey system to identify areas where uncertainty or human error is more likely to occur during actual operations. Based on these insights, I plan to improve training materials and methods to create an environment where the analysts can work more smoothly and confidently on quality control tests.
  
  Training is a crucial element that strengthens the entire quality control function and serves as the foundation of product reliability. Through this work, I aim to help foster a strong culture of quality across the department.

• Q4What do you find attractive about working at Astellas?

  It is that you can put your own ideas into practice and truly feel the responsibility and impact of contributing to product quality.

  One of the most attractive aspects of working at Astellas is the high degree of freedom to carry out work and drive improvements based on my own ideas. It’s an environment where you can identify issues, take initiative, and reflect your own creativity in both how you work and the outcomes you achieve. You can feel a strong sense of connection between your daily work and the reliability of new drug development. It’s a place where people are encouraged to take the lead, speak up about what they don’t understand, share improvement ideas, and turn them into action. For those who want to grow in a challenging field like new drug development, this environment is truly inspiring.
  
  There are also plenty of training and skill development opportunities, and Astellas is flexible in supporting individual goals. This allows me to take ownership of my own growth. Last year, I participated in a three-month training at Analytical Research Laboratory. There, I learned firsthand how new test methods are designed and what requirements must be met to ensure quality. When I discovered that each test method has a clear purpose and background to deliver safe and effective medicines to patients, I strongly felt that I should conduct quality control tests that lives up to these well-designed test methods.
  
  Through this experience, my perspective on daily testing operations changed significantly. I began making improvement proposals based on what I had learned and became more proactive in my work. At Astellas, participation in such training is actively encouraged, and the environment allows you to take on new challenges and grow on your own initiative. One of the greatest appeals of working here is that you can put your own ideas into practice and truly feel that your efforts contribute to the reliability of new medicines.

A Day in My Work Life

8:00~8:15	Arrive at the office, check emails
8:20~8:30	morning stretching exercises, morning meeting
8:30~12:00	Meeting about a system (LIMS-related matters)
13:00~15:30	Cleaning verification test
15:30~17:00	GMP training (OJT on HPLC)
17:00~17:15	Check and prepare for tomorrow’s schedule
17:15~	Leave the office

* Affiliation at the time of posting.

• Q1What is your current job description?

  To contribute to the stable supply of safe and reliable products by expeditiously and reliably conducting studies and ensuring quality based on accurate data.

  Yaizu Technology Center’s Quality Control Department has a section dedicated to quality testing of commercial and investigational drug raw materials (i.e., drug substances, excipients, and packaging materials), microorganisms, and formulations.
  I am mainly in charge of drug substance testing using high-performance liquid chromatographs, gas chromatographs, infrared spectrophotometers, and other analytical instruments to qualitatively and quantitatively assess their active ingredients and check for impurities, and to ensure they conform to drug manufacturing specifications using accurate data. I contribute to the stable supply of high-quality pharmaceutical products by completing tests accurately and quickly so as not to affect the manufacturing schedule.
  I am also part of an interdepartmental Foreign Matter Analysis Team. Our analyses cover all pharmaceutical products, investigational drugs, raw materials, and formulations. They include foreign substances found in raw materials or generated in manufacturing processes, and those related to product complaints from healthcare providers, such as analyzing broken tablets. Contamination by foreign matter is strictly prohibited in pharmaceuticals on which patients’ lives depend. To ensure the continued delivery of safe and reliable pharmaceuticals to patients, we strive to reduce the risk of contamination by expeditiously performing analyses, identifying the cause of contamination, and working with the Manufacturing Department and other relevant departments. The work of the Foreign Matter Analysis Team also allows me to learn about topics other than raw materials so it has helped broaden my knowledge and perspectives, which in turn gives me a feeling of personal development every day.
  Since starting this job, I have realized the importance of such awareness.
  Even if our test results fall within the reference range, it is essential to notice anything unusual and to explore the potential causes of anomalies from various perspectives. When analyzing foreign matter, it is crucial to notice and estimate potential sources of foreign matter risks based on identified elements. We are constantly noticing and investigating these risks on a daily basis, and we implement the necessary improvements to achieve even higher levels of quality control.
  All of our work involves a great deal of responsibility. We strive to realize ever-higher levels of quality control, and engage in our work with a genuine sense of urgency and responsibility. I feel that my work contributes to Astellas' drug manufacturing, which is very rewarding in itself.

• Q2When do you find work interesting or difficult?

  When I’m challenging myself to learn analytical techniques for new drug substances.

  At the Yaizu Technology Center, new products have been launched every year since I joined the company, and I have been involved in the quality testing of several new drug substances. To perform quality testing of new drug substances at the Yaizu Technology Center, analytical technology transfers are needed to acquire the necessary analytical technology from laboratories with relevant expertise or from drug substance manufacturing sites outside Japan. Many things don’t go smoothly or are uncertain when we study a new test method for the first time. We overcome these issues and uncertainties by consulting with our experienced senior staff and by working closely with laboratory personnel to gather the information needed to facilitate future testing. The process of solving problems one by one is interesting despite the inherent difficulties because it allows me to expand my knowledge of testing methods and analytical equipment. What’s more, solving problems in an ad hoc manner is certainly not ideal for ensuring the stable operation of quality testing in compliance with GMP. It is crucial to implement systems that guarantee a consistent testing environment in which all analysts can perform tests with the same degree of precision and without error, regardless of when or under what circumstances the test is performed. I feel challenged on a daily basis, not only in terms of my skills and knowledge of testing methods and equipment, but also because I need to a flash of idea as an analyst and to be flexible in my ideas; however, I find it interesting.

• Q3what challenges would you like to take on in the future?

  I would like to try analyzing new fields such as antibody drugs and biopharmaceuticals.

  To date, the Yaizu Technology Center has been manufacturing pharmaceuticals, primarily solid preparations (small molecule drugs), but we have now started manufacturing antibody drugs. I was fortunately involved in the transfer of analytical technologies for antibody drugs. Because antibody drugs have entirely different properties and characteristics from those of small molecule drugs, we have to perform tests using new equipment that we have never handled before and there are many things that we cannot understand using our existing expertise and technologies in the analysis of small molecule drugs. I hope to learn more about antibody drugs, various analytical techniques, and equipment so as to minimize the potential unknowns that we may encounter. I would also like to further my knowledge of various national regulations and contribute to developing GMP-compliant systems that will ensure higher quality control levels. In the future, I intend to challenge myself to become a more capable analyst not only of small molecules and antibody drugs, but also new biopharmaceuticals, with the aim of developing the analytical skills and knowledge required to handle a wide range of drugs.

• Q4What is the appeal of working at Astellas?

  I feel the most attractive point is that I can continue to contribute to patients around the world who are waiting for medicines.

  Astellas is a company that continues to pursue challenges in the development of new drugs. We are focused not only on our specialist fields but also on research and development of advanced and cutting-edge drugs targeting viruses and cells. This approach allows me to feel involved in the future development of various new drugs even while working in manufacturing, which is the most appealing aspect of the job.
  Although it doesn’t directly result in the creation of new drugs, quality control work is vital for ensuring that the highest quality drugs are delivered to patients as expeditiously as possible. This is a rewarding job where I can play a part in constantly delivering safe and reliable medicines to patients around the world through drug quality assurance based on accurate data.
  Astellas also has many departments covering research, medical & development, pharmaceutical technology, engineering, manufacturing, and marketing. These different departments handle everything from drug research and development to manufacturing and sales. I believe that the appeal of Astellas is that the various departments within the company allow us to closely collaborate efficiently to ensure the stable supply of medicines. The Yaizu Technology Center where I work comprises not only the plant but also the Formulation Research Center and Materials Research Center on the same site, and this layout facilitates interdepartmental communication. By sharing opinions from various perspectives and working closely together, we are able to manufacture investigational drugs, launch new products quickly, and ensure a stable supply of existing products.

A day in the life of Yoshie Maeda

8:15	Arrive at office, check email, participate in radio calisthenics
8:25	Team meeting, training
8:40	Review analytical data from previous day
9:00	Testing or sampling
12:00	Lunch
13:00	Continue tests (prepare documents in between testing) or attend meetings
16:00	Check and summarize analytical data for the day, pack up
17:00	Prepare testing for the next day and check schedule
17:15	Return home

* Affiliation at the time of posting.