Senior Lab Director, Precision Medicine Operations

Precision Medicine Group; Frederick (MD); On-site; USD 180,000 - 320,000; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement benefits

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group in Frederick, MD seeks an Executive Director / Site Head to lead the Frederick laboratories. The role requires deep FDA regulatory knowledge and experience managing Bioanalysis, Flow Cytometry and CDx operations on-site.

You will mentor lab heads, ensure CAP/CLIA/GxP compliance, and drive operational excellence while coordinating with QA, Facilities and Finance to meet KPIs and budgets.

Qualifications

• PhD in Immunology or related field
• 20+ years of relevant experience
• 15+ years of leadership experience
• Experience with regulatory audits and FDA guidance
• Deep knowledge of GLP, GCP or GCLP standards and ISO 13485

Responsibilities

• Oversee lab operations across Frederick, including Bioanalysis, Flow Cytometry and CDx.
• Mentor and coach laboratory heads; collaborate with QA, Facilities, and Finance.
• Ensure regulatory compliance with CAP/CLIA/GxP and CLSI; participate in FDA calls.
• Monitor KPIs such as quality events, turnaround time, capacity and budget adherence.

Skills

Leadership experience

Regulatory knowledge

GLP/GCP/GCLP expertise

CAP/CLIA/CLSI/ISO 13485 knowledge

Communication skills

MS Office proficiency

Supervisory experience

Education

PhD in Immunology or related field

Job description

Precision Medicine Group in Frederick, MD seeks an Executive Director / Site Head to lead the Frederick laboratories. The role requires deep FDA regulatory knowledge and experience managing Bioanalysis, Flow Cytometry and CDx operations on-site.

You will mentor lab heads, ensure CAP/CLIA/GxP compliance, and drive operational excellence while coordinating with QA, Facilities and Finance to meet KPIs and budgets.