Executive Director/Site Head
Core
Oversee laboratory operations across Bioanalysis, Flow Cytometry, and Companion Diagnostic groups to ensure scientific excellence and regulatory compliance.
Role type
Executive Director / Site Head
Builds
Robust assays and validated laboratory processes for clinical studies
Domain
Life Sciences / Clinical Diagnostics / Bioanalysis
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA guidance knowledge, assay development (cell-based and non-cell-based), regulatory compliance (CLIA, CAP, GxP, ISO 13485), leadership of lab heads, operational excellence, budget management, SOP development
Preferred skills
CRO/Biotech/Pharma experience, ECL, ligand-binding assays (LBA), cell-based plate assays, enzymatic activity assays
Technologies
ECL, ligand-binding assays (LBA), cell-based plate assays, flow cytometry, enzymatic activity assays
Responsibilities
Oversee operational aspects of Bioanalysis, Flow Cytometry, and Companion Diagnostic labs; Support, hire, coach, and mentor laboratory lab heads; Monitor and report site KPIs including quality events, turnaround time, capacity, revenue, and budget; Improve operations and enhance operational excellence; Establish best practices for business operations processes; Prepare and review critical documents including protocols, reports, and SOPs; Troubleshoot and correct scientific issues; Act as an escalation point for clients; Ensure compliance with regulatory guidelines (CAP/CLIA/GxP)
Seniority
Executive, strategic leadership & operational oversight
