Specialist - Large Molecule Biocritical Reagents
Core
Manage the Integrated Risk Management (IRM) program for critical biomaterials used in Large Molecule (LM) QC assays to ensure reliable assay performance and supply continuity.
Role type
Specialist, hands-on IC in biomaterial lifecycle and risk management
Builds
Harmonized lifecycle management for critical biomaterials and QC assays
Domain
Life sciences / Pharmaceutical QC / Biomaterials
Required skills
Integrated Risk Management (IRM) program management, biomaterial lifecycle management, risk identification and mitigation, data evaluation and reporting, project management, technical documentation, assay troubleshooting, stakeholder communication
Preferred skills
Experience with LIMS and document management systems, data analysis tools, Dutch language proficiency
Technologies
LIMS, document management systems, Excel
Responsibilities
Collect and structure technical information for critical biomaterials including availability, criticality, and qualification status; Define and monitor mitigation roadmaps for supply risks; Support characterization and qualification activities for new or replacement biomaterial batches; Assist in biomaterial-related investigations and troubleshooting by analyzing assay data; Establish realistic replacement timelines and minimum stock limits; Contribute to standardizing procedures and improving documentation quality
Seniority
Mid-level, hands-on IC