Leading article
Renji Oritsune
A production supervisor once asked me whether an unexpected result was important enough to delay the schedule. I was a young process engineer and did not yet have the experience to answer well. I could explain the observation, but I had not learnt to distinguish what we knew from what we wanted the result to mean. The discussion stayed with me because the schedule was real, the uncertainty was real, and a vague instruction to exercise judgement did little to help either person.
I joined Kisarame Laboratories in April 1992, immediately after graduating in chemical engineering from Tsukerano Institute. My first work concerned process documentation and equipment changes in established medicines manufacturing. I collected operating data, helped investigate departures from expected conditions and prepared technical material for more experienced colleagues to review. I did not make batch-release decisions. Learning the boundary of my authority was as important as learning the process, because a persuasive engineering explanation was not the same thing as an authorised quality conclusion.
In April 1998 I moved into a quality-operations management role at Kisarame. The change brought me closer to the records on which manufacturing decisions depended. I found that a long investigation was sometimes waiting for a specialist, sometimes waiting for a well-framed question and sometimes waiting for someone to admit that the first explanation was insufficient. Treating every delay as poor administration obscured those differences. I began reviewing the work remaining and the capability needed, alongside how long the file had remained open.
I joined Nerukawa Biologics as site head in January 2004. Despite its name, the site I led concentrated on established sterile hospital products, with a small development-support unit elsewhere in the company. My remit included production, engineering and site operations, while quality release authority remained with the designated quality organisation. I had to learn that respecting this separation meant more than avoiding direct interference. It also meant ensuring that the operating plan did not repeatedly leave quality colleagues to absorb a capacity problem at the final step.
The site role was my first experience of carrying a substantial operating budget. We had 310 employees and annual site expenditure of approximately ¥8.4 billion. An early improvement programme increased equipment availability, but the additional output created pressure in testing and documentation. I revised the plan rather than celebrate the production result in isolation. The experience changed how I evaluate investment: a machine's capacity is useful only within a complete path from materials through review and authorised dispatch.
In October 2009 I became chief supply officer at Nerukawa. I coordinated planning, procurement and distribution across two domestic sites. The role exposed commercial assumptions that manufacturing teams had previously received as fixed requirements. Product variants, minimum order quantities and launch timing could each consume capacity without appearing in the headline demand forecast. I introduced a review of these commitments with commercial and quality colleagues, including the circumstances in which the business would decline an attractive order rather than compress the work required to support it.
Aoritsune Therapeutics recruited me as chief operating officer in April 2014. It was a listed mid-cap business with a continuing minority holding by the founding family. I was not a member of that family, and my appointment was an operating mandate rather than a succession entitlement. I worked across three sites and helped the executive team connect capital planning with product economics and quality-system capacity. The board wanted more dependable supply, but it also expected a credible explanation of the expenditure and inventory needed to achieve it.
I took the chief executive role in July 2019. The company then needed to address an ageing investigation register and several supply dependencies that had been accepted for too long. I protected specialist time for the former and approved a selective alternative-source programme for the latter. Neither became a simple success story. Some investigations remained open because the evidence did not justify closure. Two alternative sources did not complete qualification, and the six that did increased annual cost. I wanted those qualifications visible to directors, not removed from the headline.
The question of expansion has required similar restraint. A proposed ¥7.2 billion project promised additional output, but its original model treated laboratory and release work as if they would scale automatically. We separated the enabling work from the later capacity decision. That changed the investment timetable and disappointed colleagues who had prepared a complete construction programme. It also gave us a more useful account of the constraint. I would rather explain a revised sequence to investors than ask a site to meet a promise whose supporting work has not been funded.
I now spend much of my time making room for difficult operational evidence in executive discussions. This is not an argument for permanent caution or a belief that uncertainty can be eliminated. A medicines company must make decisions with incomplete information. I want the uncertainty described by people close enough to understand it, the relevant authority respected and the commercial consequence accepted by those who own the plan. That is the habit I would bring to an external board as well as the organisation I lead.