Newsletter #8. Late insight as a structural risk in pharma manufacturing.

Curated by Fabrice Gribon, Founder of Gribon & Company
Practical, field-tested insights on operational excellence and business transformation — for Site Heads and Operations Directors.

The context

Operations leaders in biopharma manufacturing navigate an environment characterized by immense pressure to maintain manufacturing stability while accelerating throughput and managing complex regulatory demands. The current landscape often forces site heads and COOs into a reactive posture, where daily operational issues consume resources and attention. Despite internal efforts to establish governance models, improvement programs often stall because they address symptoms without a clear, collective understanding of the underlying systemic risks. This dynamic creates a cycle where problems, seemingly managed, relentlessly resurface, undermining sustained operational performance.

Structural issues eat performance

The fundamental misstep most organisations make is underestimating the insidious nature of late insight. What's consistently absent is a comprehensive, real-time understanding of operational dynamics, leading to a predominantly reactive posture. The industry typically accepts "firefighting" as the norm, addressing problems only after they have escalated into critical incidents, such as production delays or quality excursions, deviations. This challenges the widely accepted assumption that robust quality systems alone guarantee proactive management; without timely data, even the most rigorous quality processes become retrospective.

A critical oversight in how companies approach operational risk anticipation is the prevalence of data silos. Information fragmentation across disparate systems—from R&D to production and quality control often prevents a holistic view of the manufacturing process. This lack of end-to-end operations visibility hinders effective decision-making. Our surveys and interviews across several projects, indicate that a significant majority of respondents believe that data fragmentation impedes their capabilities. Consequently, a substantial portion of existing manufacturing capacity, often 20-40%, remains unutilized, representing a "hidden factory" of lost throughput, lost patient treatments and missed financial performance gains. This untapped potential stems from process variability, suboptimal equipment performance, and inefficient changeovers, all obscured by delayed or incomplete biopharma performance insights.