Scientist, Quality

Meso Scale Diagnostics, LLC.; Rockville (MD); On-site; USD 78,000 - 116,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with company matching

Flexible spending accounts

Disability insurance

Job summary

Meso Scale Diagnostics, LLC is seeking a Quality Scientist to independently manage testing, technical transfer, and troubleshooting of protein-based immunoassays. The role may supervise others and collaborates with cross-functional teams to improve product and process quality.

Responsibilities include data analysis, MRB coordination, and CAPA initiation—while ensuring compliance with MSD processes and SOPs. A strong foundation in molecular biology and quality systems is essential.

Qualifications

• Bachelor's degree in a relevant field with 4+ years of experience required.
• Experience leading cross-functional teams and CAPA/ MRB processes.
• Strong background in protein-based immunoassays or related bioassays.
• Familiarity with quality systems, SOPs, and data integrity practices.

Responsibilities

• Review testing data and investigate failures; monitor product/process performance.
• Lead CAPA activities and MRB discussions, coordinating cross-functional teams.
• Present data-driven conclusions and recommendations to senior management.
• Develop and revise SOPs, test records, and product specifications.

Skills

Statistical analysis

Data analysis

Leadership

Communication

Project management

Teamwork

Problem solving

Attention to detail

DOE

Presentation skills

Education

Bachelor's degree

Tools

MS Office

MATLAB

MiniTab

Job description

Job Category: Quality - Control/Assur/Regul

Requisition Number: SCIEN003870

• Posted : August 20, 2026
• Full-Time

Locations

Showing 1 location

Rockville, Maryland
Rockville, MD 20850, USA

Description

POSITION SUMMARY:
A Quality Scientist is responsible for independently managing the testing, technical transfer, and advanced troubleshooting of protein-based immunoassays. A Quality Scientist is expected to manage the process of troubleshooting multiple non-conforming products and independently manage multiple high-impact projects to improve product and process quality. This position may supervise the work of others directly and/or across interdisciplinary teams.

• Review testing data and perform analyses including investigations of failures, as well as process and product performance trending and monitoring.
• Provide descriptive statistical analysis using clear and concise methodologies and ensure accuracy and validity of data.
• Perform data analytics including process and product performance trending and monitoring. Analysis includes identification of process and product improvements.
• Present experimental conclusions, recommendations and proposed initiatives to cross-functional and/or senior management teams.
• Lead Material Review Board (MRB) meetings and facilitate discussions.
• Initiate, coordinate, and/or be the Technical Lead of CAPA documents (Deviations, Non-Conforming Material Report (NCMR), etc.).
• Establish and monitor staff performance and development goals, assigns accountabilities, sets objectives, establish priorities, and provide continuous feedback and recognition on performance.
• Identify process and product improvements using product data and metrics as a guide.
• Ensure testing and process documentation complies with MSD processes. Develop, revise and implement SOPs, Test Records, and product specification documents, as required.
• Specific duties may vary based on departmental requirements.

• Bachelor’s degree and 4 years of experience in relevant field is required.
  • Additional education may be substituted for experience.
  • Additional experience may be substituted for degree.
• Supervisory/management experience desired.

• Strong scientific fundamentals and analytical background.
• Demonstrated understanding of protein-based immunoassays and techniques is required.
• Knowledge of laboratory safety precautions and proper use of personal protective equipment.
• Knowledge of protein-based immunoassays execution, development, and optimization.
• Ability to troubleshoot immunoassays and reagents using logical problem solving and root cause analysis.
  • Design of experiments (DOE) is preferred.
  • Ability to improve product performance and articulate solutions to broad cross-functional teams.
• Demonstrated aptitude for learning and applying new techniques and methodologies.
• Strong understanding of basic molecular biology techniques and their application.
• 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.
• Strong business acumen, negotiation and mediation skills, as well as a demonstrated attention to detail and a focus on achieving quality outcomes.
• Ability to build/foster relationships.
• Demonstrated ability to present technical data.
• Data integrity understanding and practices.
• Ability to prioritize and manage multiple, complex tasks in a fast-paced environment under tight deadlines.
• Excellent oral, written communication and interpersonal skills are required.
  • Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data.
• Proficiency in MS Office suite
  • Strong knowledge of standard data analysis tools and databases
• Familiar with Matlab, MiniTab or other statistical software analysis tools is preferred.

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:
Standard office environment

COMPENSATION SUMMARY:

The annual base salary for this position ranges from $78,100 to $116,200. 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:

• medical, dental, and vision coverage, along with prescription benefits
• a 401(k) plan with company matching
• flexible spending accounts
• company-paid short- and long-term disability insurance
• group life and accidental death and dismemberment insurance
• paid vacation
• paid sick leave
• paid holidays
• paid parental leave, along with an employee assistance program
• fitness club membership contribution
• pet insurance
• identity theft protection
• home and auto insurance discounts
• 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. 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 .

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.

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

Qualifications

Education

Required

Bachelors or better.

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.