Laboratory Manager
Core
Managing laboratory operations within a multi-disciplinary R&D environment to support the development of in vitro diagnostic (IVD) products.
Role type
Senior Laboratory Manager (R&D)
Builds
In vitro diagnostic (IVD) products
Domain
Healthcare diagnostics / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Laboratory operations management, FDA QSR and ISO 13485 compliance, biosafety program management, laboratory equipment lifecycle management, PCR workflow design, audit support, continuous improvement
Preferred skills
Regulated environment experience (IVD, medical device, biotech, pharma), advanced knowledge of FDA QSR and ISO 13485, biosafety program expertise
Technologies
PCR systems, analytical instruments, freezers, centrifuges, balances, pipettes
Responsibilities
Resolve complex laboratory operational issues, ensure compliance with Abbott Quality Systems and biosafety standards, establish and enforce PCR laboratory workflow design, implement controls to prevent cross-contamination, maintain inspection-ready laboratories, manage equipment lifecycle and maintenance, oversee sample handling and biorepository operations, drive continuous improvement initiatives
Seniority
Senior, hands-on IC
