Executive Director, Laboratory Operations — Precision Medicine

Precisionmedicinegroup; Frederick (MD); On-site; USD 203,200 - 304,800; Full time

Benefits offered by this job

Discretionary bonus

Health insurance

Retirement benefits

Life insurance

Paid time off

Job summary

Precision Medicine Group seeks an Executive Director / Site Head of Precision for Medicine, onsite in Frederick, MD, to oversee three laboratory groups, optimize processes, and ensure regulatory compliance. You will translate FDA guidance into robust, passing assays, shaping GLP/GCP/GCLP programs and QC systems across Bioanalysis, Flow Cytometry, and CDx.

The role requires deep regulatory knowledge, 20+ years in the field, and 15+ years in leadership, with strong interpersonal skills to mentor

Qualifications

• PhD in Immunology or a related field required.
• 20+ years of relevant experience; 15+ years in leadership.
• Strong knowledge of GLP/GCP/GCLP standards and regulatory audits.

Responsibilities

• Oversee operations of Bioanalysis, Flow Cytometry, and CDx labs in Frederick, MD.
• Hire, coach, and mentor laboratory heads; drive operational excellence.
• Ensure regulatory compliance with CAP/CLIA and CLSI; manage budgets and KPIs.
• Communicate with clients and stakeholders; provide technical updates and escalation support.

Skills

Leadership experience

Regulatory knowledge

English proficiency

Cell-based assays knowledge

Education

PhD in Immunology or related field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Precision Medicine Group seeks an Executive Director / Site Head of Precision for Medicine, onsite in Frederick, MD, to oversee three laboratory groups, optimize processes, and ensure regulatory compliance. You will translate FDA guidance into robust, passing assays, shaping GLP/GCP/GCLP programs and QC systems across Bioanalysis, Flow Cytometry, and CDx.

The role requires deep regulatory knowledge, 20+ years in the field, and 15+ years in leadership, with strong interpersonal skills to mentor