Associate Director, Bioanalytical Laboratory

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

Associate Director, Bioanalytical Laboratory

Job Category: Quality - Control/Assur/Regul

Requisition Number: ASSOC003942

• Posted : October 7, 2026
• Full-Time

Locations

Showing 1 location

Gaithersburg, Maryland
Gaithersburg, MD 20877, USA

Description

POSITION SUMMARY:

This position is responsible for planning, organizing and directing bioanalytical principal investigator and sample testing resources of a bioanalytical laboratory performing assay validations and sample analysis. The Associate Director, Bioanalytical Laboratory is a subject matter expert in one or more types of assays run on the MSD platform and provides technical guidance for bioanalytical methods developed and used in the laboratory, as well as ensuring laboratory and employee proficiency in these methods. This role also provides input to senior management in developing the group’s overall strategies and business plans.

DUTIES AND RESPONSIBILITIES:

• Responsible for bioanalytical laboratory resources performing assay validations and sample analysis, including compliance with regulatory standards.
• Implements and maintains laboratory procedures, information systems, documentation and processes compliant with applicable elements of Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP).
• Provides leadership and management to staff consistent with applicable GLP and GCLP requirements.
• Ensures that all direct and indirect reports receive the appropriate training for the type and complexity of the services offered; manages associated training plans to ensure training is kept current; and evaluates and addresses training and/or continuous education needs of their staff.
• Ensures all operations are performed in accordance with released SOPs, quality control and safety requirements.
• Ensures laboratory procedures, methods and staff produce high quality services through a combination of observation and data evaluation.
• Provides input regarding budgets for laboratory operation, including staffing, operating expenses, materials and capital equipment.
• Participates in the human resource management functions including hiring, orientation and training.
• Coordinates, along with head of laboratory operations and senior laboratory management, daily operations of the laboratory, including testing and staff schedules.
• Represents the organization in a positive and professional manner in meetings with customers.
• Maintains appropriate accessibility to the laboratory at all times.
• Establishes and monitors staff performance and development goals, assigns accountabilities, sets objectives, establishes priorities, and provides continuous feedback and recognition on performance. Helps identify high performers to groom for potential succession planning.
• Promotes a culture of high performance and continuous improvement that values learning and a commitment to quality.
• Participates in professional conferences and workshops and presents results of BAL projects.

EXPERIENCE AND QUALIFICATIONS:

• Ph.D. in Biology, Chemistry, or related scientific discipline is preferred.
• Master’s degree may be substituted with additional relevant experience.
• A minimum of 8 years of overall experience in immunoassay development in an industrial environment or bioanalytical sample testing in a GLP/GCLP environment in positions of increasing responsibility is required.
• A minimum of 4 years of experience managing biomarker development and/or bioanalytical sample testing projects and directly or indirectly managing associated resources is required.
• Training in and experience with GLP/GCLP is required.

KNOWLEDGE, SKILLS AND ABILITIES:

• Knowledge of laboratory information systems, data review and analysis, quality assurance and management systems.
• Broad knowledge of laboratory operations including expertise in immunoassay validation.
• Knowledge of GLP/GCLP requirements as applicable to bioanalytical sample testing.
• Knowledge of safety aspects of working with biological hazards.
• Outstanding interpersonal communication skills, including presentation and training skills.
• Thorough understanding of the principles of immunoassays, their development and their applicability in different research fields.
• Superior analytical skills and strong scientific fundamentals.
• Professional presence and strong interpersonal skills for interacting in a courteous, timely, and diplomatic manner with all levels of employees as well as other parties/stakeholders involved with the company.
• Demonstrated critical thinking and analytical skills, as well as the ability to handle complex situations and demonstrate sound judgment and problem solving.
• Excellent organizational, planning, and time management skills with the ability to manage multiple and often changing priorities and issues of varying complexity, while meeting time-sensitive deadlines and deliverables.
• Solid leadership skills with demonstrated knowledge and understanding of staff management practices and processes and the ability to establish accountabilities and expectations and manage performance to achieve results.
• Attention to detail with a demonstrated commitment to excellence and performance improvement and the drive to deliver quality and value-added results and outcomes.
• Proficiency in MS Office Suite.

PHYSICAL DEMANDS:

This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.

WORK ENVIRONMENT:

This position is performed in a traditional office environment with periodic requirements to work with laboratory personnel in their designated work areas.

COMPENSATION SUMMARY:

The annual base salary for this position ranges from $151,400 to $236,600. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate’s knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success.

BENEFITS SUMMARY:

At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance.

EEO/AA STATEMENT:

MSD is an Equal Opportunity/Affirmative Action Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO/AA and Pay Transparency statement, please click on the following link: https://www.mesoscale.com/en/our_company/careers/equal_employment_opportunity_statement.

Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.

Qualifications

Education

Preferred

PHD or better in Biology or related field.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.