Associate Director, Bioanalytical Lab — Immunoassay Strategy

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

Benefits offered by this job

401(k) plan with company matching

Paid vacation

Paid holidays

Job summary

Meso Scale Diagnostics, LLC. seeks an Associate Director, Bioanalytical Laboratory to lead the bioanalytical laboratory, ensuring assay validations, sample testing, and GLP/GCLP compliance. The role guides methodologies, staff proficiency, and strategic planning for BAL operations.

Ideal candidate has strong leadership, deep immunoassay knowledge, and experience with biomarker development or project management in a regulated environment.

Qualifications

• Ph.D. in Biology, Chemistry, or related field preferred.
• Minimum 8 years of immunoassay development or GLP/GCLP bioanalytical experience.
• Minimum 4 years managing biomarker development or bioanalytical projects.
• Training in GLP/GCLP is required.

Responsibilities

• Lead resources for assay validations and sample analysis with GLP/GCLP compliance.
• Coordinate daily lab operations and staff scheduling.
• Develop and implement SOPs and ensure quality control systems.
• Manage training plans and staff development initiatives.
• Represent the organization professionally in meetings with customers.
• Assist with budgeting and capital equipment planning.

Skills

Leadership

Immunoassay development

GLP/GCLP knowledge

Quality systems

Biomarker development

Education

Ph.D. in Biology, Chemistry, or related

Master’s degree may substitute with experience

Tools

Laboratory information systems

MS Office Suite

SOP/document control tools

Job description

Meso Scale Diagnostics, LLC. seeks an Associate Director, Bioanalytical Laboratory to lead the bioanalytical laboratory, ensuring assay validations, sample testing, and GLP/GCLP compliance. The role guides methodologies, staff proficiency, and strategic planning for BAL operations.

Ideal candidate has strong leadership, deep immunoassay knowledge, and experience with biomarker development or project management in a regulated environment.