Jeff van Doren

Experience

1. Global Analytical Instrument Lifecycle Management Lead

   Takeda

   Jan 2019 — Present · Lexington, MA, US

   Provide global direction of the network QC labs with respect to knowledge related to analytical instrument qualification, lifecycle management, equipment maintenance, calibration, regulatory compliance & global policies as they relate to QC instrumentation. Partnering with the Global Data Integrity Program team and Site DI Leads to ensure compliance with the analytical instruments. Supporting Lab Excellence Academies on DI & analytical instrument topics. Leading Community of Practices to understand best practices, communicate audit trends and findings, address issues, and raise capabilities at the sites.Integrating analytical instrument lifecycle management with promising and innovative new technologies as well as standardization of instrument types across the labs, which chooses suppliers and instruments based on “common minimal”, i.e. “right, fit-for-purpose”, compliance requirements, to ensure real to-date compliance by design based on deep technical & science based knowledge, including standardization by sharing the already executed and compliant AIQ documents to alleviate their qualification effort.Driving Operational Excellence across the Organization, which includes leading the realization of scalable COBOTs, implementing XR (Augmented, Mixed, Virtual- Reality) for remote assist and digital instruction capabilities, implementing Robotic Process Automation use cases in QC, leading the QC labs in the realization of a Manufacturing & Lab Security (MLS) program, and realizing digital solutions for trending and monitoring of data.Executing strategic global projects and representing global labs for Paperless Validation Processes and Global LIMS implementation for Instrument Management workstreams.

Skills

• Technology Transfer
• Validation
• Capa
• Lifesciences
• Gmp
• Glp
• Hplc
• R&D
• Assay Development
• Biotechnology
• Elisa