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FUJIFILM Biotechnologies is a global contract development and manufacturing organization (CDMO) that partners with pharmaceutical and biotechnology companies to develop and produce biologics, vaccines, and gene therapies.

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  • Developed a resin contamination response and remediation plan by integrating data from QA, QC, Process Engineering, EHS, and global vendor partners, resulting in updated SOPs, decision trees, and process flow diagrams adopted for site readiness.

  • Supported deviations management by creating investigation checklists, process maps, and efficiency-driving tools while coordinating TrackWise change controls for recipe-driven operations.

  • Gained hands-on experience with GMP systems including Veeva, TrackWise, CEBA, DeltaV, and MES; contributed to commissioning, qualification, and validation activities during large-scale CDMO site startup.

  • Presented technical findings to the Site Leadership Team and collaborated cross-functionally across manufacturing, quality, MSAT, and automation to drive operational improvements.

Drug Substance Manufacturing (DSM) Support and Deviations Management Intern

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