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Someone who leads drug manufacturing projects by building new experiences for her own self-growth.

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  • # APIProcessDevelopment

Naoko Suzuki

Pharmaceutical Technology Div.
CMC Development Dept.
Since 2016

  • University

    Majored in environmental science at graduate school and completed a master’s degree.

  • 1st year

    Joined the Japanese subsidiary of a foreign chemical manufacturer. Engaged in research on polymeric fluids at the headquarters laboratory in Europe. Started working in development of contracted synthesis business newly launched in Japan in her 3rd year.

  • 9th year

    Joined Chugai Pharmaceutical. Engaged in Contract Manufacturing Organization (CMO) management and contract management.

  • 11th year

    Temporarily transferred to Genentech in the United States. Gained experience in project management and selection of companies for drug manufacturing CMOs in North America.

  • 12th year to present

    Transferred to CMC Development Department and took a leading role in drug manufacturing functions of a development project. Took maternity and childcare leave during that period.

Worked hard on business development at her previous company.

Naoko Suzuki came to Chugai Pharmaceutical after working at a major foreign-owned chemicals manufacturer. She joined the manufacturer as a new graduate after majoring in chemical engineering at graduate school because she was attracted by the opportunities that company offered for young employees to pursue careers overseas. Soon after joining the company, she was transferred to a laboratory in Europe and engaged in basic research of polymers for about two years. After returning to Japan, she was given the opportunity to be involved in the development of a contract manufacturing organization (CMO) business. ‘While discussing what my position would be on my return to Japan, I learned that the foreign manufacturer was about to acquire a company that conducts a CMO business in the synthesis of drug substances and intermediates of small molecule compounds, and that it was going to launch this kind of business in Japan. I was fortunate to be able to participate in the expansion of that business. I found that work very interesting, and I was able to build a meaningful career there.’

At the time, Suzuki was working on the expansion of the contracted synthesis business in Japan and the establishment of the scheme itself. She developed leads with potential client drug manufacturers and established a supply chain from scratch of her own accord. While feeling a great sense of achievement, just as the business was getting on track, she found herself wanting to take on new challenges. ‘After being involved in the business for about six years, I felt that I had achieved everything that I could there, and I started thinking about growing in a new field. Around that time, the business was to be sold, and I learned that Chugai Pharmaceutical, with whom I had been dealing at the time, was recruiting for a position that would allow me to make use of my past experience. I felt the significance of being involved in the pharmaceutical industry, which makes such a huge contribution to society, and I decided to join Chugai Pharmaceutical because I wanted to take this opportunity for my next challenge.’

Days of struggle in the United States helped her grow.

Immediately after joining the company, Suzuki was assigned to the management of the CMOs with whom Chugai Pharmaceutical deals. ‘I was now working in a position that was on the opposite side of the dealings that I was involved in at my previous employer. Thanks to my previous experience, I had a good understanding of the situation at CMOs, which I think allowed me to proceed smoothly with contract negotiations. I was also able to demonstrate my abilities without any feeling in any way inadequate.’ After working in this position for two years, Suzuki was sent on temporary transfer to Genentech in the United States. ‘When my supervisor offered me the opportunity, I said yes immediately. At Genentech, I was also assigned to the management of local CMOs to whom the company had contracted drug production. In this position, I was involved in the CMOs’ operations more deeply, which gave me many opportunities to learn.’

She was in charge of a bio-drug CMO, so she was required of familiarize herself with bio-drug production so she could manage it properly. However, Suzuki’s specialty is chemical engineering, and she had little knowledge of bio-science. ‘I started by studying up on bio-drugs. With the support of my supervisor, I was able to shadow a worker at the factory for several weeks and to participate in outside workshops. Every time there was a problem, such as deviations from the prescribed process at the CMO to whom we had outsourced the production, I took actions such as pointing out insufficient investigation of the cause and suggesting measures to ensure that the same thing would not happen again, based on discussions with the CMO and reading the various reports thoroughly. It was very challenging work, as the deviation report had to be completed before shipment, and either our side or the CMO side would run out of time every time. However, I personally believe that I gained invaluable experience, because I was able to deepen my understanding of the processes and quality control.’ Since returning from her one-year secondment, Suzuki is currently working as the leader of the CMC team of a bio-drug development project.

Promoted to manager while raising young children.

CMC is short of Chemistry, Manufacturing and Control. It refers to the series of processes that are necessary to produce actual drugs, including drug substance research, drug product research, quality assurance, and quality control. Suzuki’s role is to compile this CMC and move the development project forward. ‘We formulate manufacturing plans in line with the development plan of the project and proceed with development of manufacturing and analysis methods. My role is to bring the leaders of the respective divisions, such as drug substance, drug product, quality assurance, and quality control together and to manage CMC activity so that the drugs can be produced in accordance with the timeline. If there are any problems in the project, I work together with the other members to come up with appropriate measures by looking at the whole picture so we can keep the project moving. I feel a sense of reward when I am able to overcome difficulties with the other members.’

Suzuki says that Chugai Pharmaceutical actively gives opportunities to its mid-career hires, regardless of gender, that allow them to take on new challenges and build up their careers. ‘I knew nothing about bio-drugs before I joined Chugai Pharmaceutical, but now I have an important role in a bio-drug development project. Naturally, I have a lot to learn every day, but I love being able to stretch myself by absorbing new knowledge. I gave birth to my child after being assigned to my current position, but I was promoted to a management position less than a year after I returned from childcare leave. I had never dreamt that I could be promoted to a management position because I was working reduced work hours while my child was small, so the fact that I was promoted gave me a renewed appreciation for how very fair this company is. To meet the company’s expectations, I will stretch myself even further at Chugai Pharmaceutical going forward.’

* The contents of this article are correct as of the time of interview.


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