Laboratories in the pharmaceutical industry see an ongoing transition towards continuous manufacturing by means of tighter integration of novel and existing technologies and, thus, the introduction of new work methodologies. However, technological studies focusing novel manufacturing methodologies usually do not address social aspects, while social sciences studies on the other hand rarely address scientific and industrial aspects of manufacturing processes and therein involved personnel. Hence, the scientific literature lacks systematic analyses of human and social factors in such continuous manufacturing environments. Therefore, the study provides a literature review of social research of scientific laboratories and lab work. Then, ethnographic field research is conducted in a laboratory for continuous manufacturing. One by one a team of six lab workers are observed and interviewed during a typical day shift (N=6). All sessions are recorded on video (4h 47mins) and transcribed to enable a qualitative content analysis. The overall work environment of a research and development chemistry laboratory of a big multinational pharma company is described including the general laboratory workflow. Finally, a list of 96 user needs as well as user role descriptions of the participating lab workers are generated. One key finding of the study is that the work culture in this lab follows a mode of constant debate trying to contain knowledge transfer in teams top-down as well as bottom-up, e.g. during experimenting with hardware setups trying not to compromise the chemical recipe following a research hypothesis. In this regard, digitization efforts like introducing electronic lab notebooks should prioritize to promote and support communication and collaboration over features and technological enhancements. Specifically, learning can be considered a shared responsibility to promote a common work process knowledge that is needed to successfully act and react in the context of continuously changing experiment setups and team compilations. Based on these results, the authors highlight the importance of holistic upfront user research to uncover underlying human and social factors as determinants for the success of socio-technical systems. All in all, with this study the authors provide a data set, which may serve as a foundation for future research and development projects in similar, industrial research working conditions, following a human-centered design approach.
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- TitelUser research in pharma R&D: Contextual inquiry for the elicitation of user needs in a chemistry laboratory for analytical method development within a corporate continuous manufacturing organization
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- Enthalten inJournal of Business Chemistry, H. Journal of Business Chemistry, S. 151-190
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- AnmerkungSection "Research Paper"
- SpracheEnglisch
- DokumenttypAufsatz in einer Zeitschrift
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