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 / Biotechnology / Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Integrated Risk Management (IRM) program management, biomaterial lifecycle management, risk identification and mitigation planning, technical data evaluation, protocol writing, documentation management, project management, troubleshooting and root cause analysis
Preferred skills
Stakeholder communication, standardization of procedures, data analysis
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 identified 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.
Seniority
Mid-level, hands-on IC