Senior Director, Bioanalytical Lab Operations

MSD; Gaithersburg (MD); On-site; USD 151,000 - 237,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) with company matching

Paid time off and holidays

Disability and life insurance

Job summary

MSD is seeking an Associate Director, Bioanalytical Laboratory in Gaithersburg, MD to plan, organize and direct resources for assay validations and sample testing. The role provides expert guidance on assays, ensures GLP/GCLP compliance, leads staff development, and contributes to strategic planning.

The position requires advanced degrees with substantial immunoassay experience, strong leadership, and a track record in managing biomarker development projects within a regulated environment.

Qualifications

• Ph.D. in Biology, Chemistry, or related discipline preferred.
• Minimum 8 years in immunoassay development or bioanalytical testing in GLP/GCLP environments.
• Minimum 4 years of biomarker development or project management experience.
• Training in GLP/GCLP required.

Responsibilities

• Oversee bioanalytical lab resources for assay validations and sample analysis.
• Ensure GLP/GCLP compliance across procedures and documentation.
• Lead staff training and development; manage budgets and resources.
• Coordinate daily lab operations and staff schedules with senior management.
• Represent MSD in meetings with customers and ensure high-quality outputs.

Skills

GLP/GCLP knowledge

Immunoassay validation

Leadership

Data analysis

Communication

Education

Ph.D. in Biology or related

Tools

LIMS (Laboratory Information Systems)

Job description

MSD is seeking an Associate Director, Bioanalytical Laboratory in Gaithersburg, MD to plan, organize and direct resources for assay validations and sample testing. The role provides expert guidance on assays, ensures GLP/GCLP compliance, leads staff development, and contributes to strategic planning.

The position requires advanced degrees with substantial immunoassay experience, strong leadership, and a track record in managing biomarker development projects within a regulated environment.