Bioanalytical Lab Director (GLP/GCLP & Immunoassays)

Meso Scale Diagnostics LLC; Gaithersburg (MD); On-site; USD 151,000 - 237,000; Full time

Benefits offered by this job

401(k) match

Bonus eligible

Job summary

Meso Scale Diagnostics LLC in Gaithersburg, Maryland, is seeking an Associate Director, Bioanalytical Laboratory. This role directs resources for bioanalytical assays, oversees method development, validations, and sample analysis, and provides expert guidance on immunoassay approaches while ensuring GLP/GCLP compliance.

You will lead staff, manage training, participate in budgeting, and collaborate with senior management to shape the lab's strategy and performance.

Qualifications

• PhD in Biology, Chemistry or related field preferred.
• Minimum 8 years in immunoassay or bioanalytical testing in GLP/GCLP environments.
• Minimum 4 years of biomarker development or project management experience.
• GLP/GCLP training is required.

Responsibilities

• Plan and direct resources for assay validation and sample testing.
• Ensure GLP/GCLP compliance and SOP adherence.
• Provide leadership, training, and staff development.
• Oversee budgets, staffing, and equipment planning.
• Coordinate daily lab operations with management.
• Represent MSD in client meetings and ensure quality.

Skills

Leadership

GLP/GCLP knowledge

Immunoassay validation

Staff management

Training

Regulatory compliance

Data analysis

Communication

MS Office

Education

PhD in Biology/Chemistry

MS with relevant experience

GLP/GCLP training

Tools

Laboratory Information Systems (LIS)

Job description

Meso Scale Diagnostics LLC in Gaithersburg, Maryland, is seeking an Associate Director, Bioanalytical Laboratory. This role directs resources for bioanalytical assays, oversees method development, validations, and sample analysis, and provides expert guidance on immunoassay approaches while ensuring GLP/GCLP compliance.

You will lead staff, manage training, participate in budgeting, and collaborate with senior management to shape the lab's strategy and performance.