Analytical Instrument Lifecycle Scientist
Core
Define and manage the lifecycle of analytical instruments for global QC labs, ensuring obsolescence planning, inventory visibility, and compliance with regulatory guidelines.
Role type
Senior IC analytical instrument lifecycle scientist
Builds
Instrument replacement projects, qualification status reports, and lifecycle management documentation for QC testing
Domain
Biopharmaceutical manufacturing / Quality Control (QC)
Deliverable
infrastructure
Required skills
Project management, risk-based judgment, regulatory compliance (cGMP, 21CFR, EMA, USP), stakeholder management, budget forecasting, change control management, CAPA management, data analysis, cross-functional collaboration
Preferred skills
LIMS software, trending/statistical software, drug substance/product manufacturing knowledge, microbiological methods, Microsoft Office, SAP, TrackWise, Veeva, JMP
Technologies
LIMS, SAP, TrackWise, Veeva, JMP, Microsoft Office
Responsibilities
Define analytical instrument standards for test methods and products; manage the 5-year instrument obsolescence plan; compile annual instrument forecasts for new products; maintain the global instrument register and documentation database; lead monthly project tracking meetings; support drafting of governing procedures and training; support cross-site collaboration; manage Change Controls and CAPAs; support health-authority inspections; ensure training requirements are met.
Seniority
Senior, hands-on IC
