Bioanalytical Lab Director: Immunoassay & CQI Lead

MSD; Gaithersburg (MD); On-site; USD 174,000 - 272,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) with company matching

Paid vacation and holidays

Disability insurance

Job summary

MSD in Gaithersburg, MD seeks an expert to plan, direct, and optimize a BAL with a focus on immunoassay development, biomarker and PK methods. You will guide technical strategies and supervise staff, ensuring GLP/GCLP adherence and CQI-driven improvements.

The role requires a Ph.D. in biology or chemistry (or equivalent), 10+ years in the field, and proven leadership of biomarker projects. Strong training in GLP/GCLP is expected.

Qualifications

• Ph.D. in Biology, Chemistry, or related scientific discipline preferred.
• A minimum of 10 years in immunoassay development in an industrial or GLP/GCLP environment.
• A minimum of 6 years leading Biomarker development and/or bioanalytical projects and managing resources.
• A minimum of 4 years of supervisory experience.
• Training in and experience with GLP/GCLP is required.

Responsibilities

• Oversee BAL operations ensuring GLP/GCLP compliance and safety.
• Act as SME for biomarker, IG, and PK assays; provide technical guidance.
• Establish procedures, documentation, and processes aligned with GLP/GCLP.
• Provide leadership and management to staff per GLP/GCLP requirements.
• Implement, monitor and evaluate CQI activities.
• Ensure staff training and continuous education; manage training plans.
• Oversee daily operations, staffing and scheduling of the laboratory.
• Prepare and monitor budgets for laboratory operation.

Skills

Immunoassay development

Leadership

Communication

Biomarker analysis

Quality systems

GLP/GCLP knowledge

Education

Ph.D. in Biology or Chemistry

Master's degree (relevant)

Tools

MS Office Suite

Laboratory information systems

Job description

MSD in Gaithersburg, MD seeks an expert to plan, direct, and optimize a BAL with a focus on immunoassay development, biomarker and PK methods. You will guide technical strategies and supervise staff, ensuring GLP/GCLP adherence and CQI-driven improvements.

The role requires a Ph.D. in biology or chemistry (or equivalent), 10+ years in the field, and proven leadership of biomarker projects. Strong training in GLP/GCLP is expected.