Biomarker & PK Bioanalytical Lab Director

Meso Scale Diagnostics, LLC.; Gaithersburg (MD); On-site; USD 174,000 - 272,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with company matching

Paid vacation and holidays

Paid parental leave

Fitness club membership

Job summary

Meso Scale Diagnostics, LLC seeks a senior leader for its Bioanalytical Laboratory (BAL) in Gaithersburg, MD. The role directs resources, ensures GLP/GCLP compliance, and provides SME guidance on immunoassay methods while upholding high quality services.

You will manage staffing, budgets, and training, and collaborate with senior management on strategy and continuous quality improvements to advance BAL projects and client satisfaction.

Qualifications

• PhD in Biology or related field preferred.
• Minimum 10 years in immunoassay development in industry or GLP/GCLP bioanalytical testing.
• Minimum 6 years leading biomarker or bioanalytical projects.
• Minimum 4 years supervisory experience.
• GLP/GCLP training and experience required.

Responsibilities

• Oversee BAL operations and ensure GLP/GCLP compliance.
• Act as SME for biomarker, immunogenicity (IG) and PK assays; provide guidance on methods.
• Lead training and staff development; manage budgets and resources.
• Coordinate daily lab operations and staffing; ensure timely deliverables.
• Represent the organization in meetings with customers; maintain professional relations.
• Drive CQI and performance improvement across the laboratory.

Skills

Immunoassays

Leadership

Training

Budgeting

Communication

Education

Ph.D. in Biology

M.S. in Biology

Tools

MS Office Suite

Laboratory information systems

Job description

Meso Scale Diagnostics, LLC seeks a senior leader for its Bioanalytical Laboratory (BAL) in Gaithersburg, MD. The role directs resources, ensures GLP/GCLP compliance, and provides SME guidance on immunoassay methods while upholding high quality services.

You will manage staffing, budgets, and training, and collaborate with senior management on strategy and continuous quality improvements to advance BAL projects and client satisfaction.