Executive Director/Site Head

Responsibilities

• Oversee laboratory operations for Bioanalysis, Flow Cytometry, and Companion Diagnostic groups in Frederick, MD
• Support, hire, coach, and mentor laboratory heads
• Monitor and report site KPIs including quality events, turnaround time, capacity, and budget adherence
• Manage weekly and monthly revenue reporting, cost tracking, and margin expansion
• Ensure compliance with CAP, CLIA, GxP, and FDA regulatory guidelines
• Participate in FDA calls regarding assay development and compliance
• Establish best practices for business operations and communication strategies
• Act as a scientific resource for clients and internal R&D projects

Requirements

• PhD in Immunology or a related field
• 20+ years of relevant professional experience
• 15+ years of leadership experience
• Direct experience in cell-based assays and bioanalysis of large or small molecules
• Working knowledge of CAP/CLIA, CLSI, and ISO 13485
• Solid understanding of GLP, GCP, or GCLP standards
• Experience hosting and participating in regulatory audits
• Proficiency in Microsoft Office Suite

Preferred Qualifications

• Direct experience working at a CRO, Biotechnology, or Pharmaceutical company
• Expertise in ECL, ligand-binding assays (LBA), cell-based plate assays, flow cytometry, and enzymatic activity assays

About the Company

Precision Medicine Group provides specialized services to support the development and commercialization of precision medicines.