Associate Scientist, Quality

Meso Scale Diagnostics LLC; Rockville (MD); On-site; USD 68,000 - 101,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) plan with company matching

Paid vacation and holidays

Paid parental leave

Employee assistance program

Job summary

Meso Scale Diagnostics LLC in Rockville, MD is seeking an Associate Quality Scientist to independently manage testing, transfer, and troubleshooting of protein-based immunoassays. You will address failures and document findings, guiding next steps. This role may supervise others across interdisciplinary teams.

Responsibilities include leading CAPA activities, MRB meetings, SOP development, and ensuring compliance with MSD processes while supporting safe, efficient lab operations.

Qualifications

• Bachelor's degree required with 2 years of relevant experience.
• Additional education may substitute for experience.
• Additional experience may substitute for degree.

Responsibilities

• Review testing data and perform analyses including investigations of failures and trend monitoring.
• Provide descriptive statistical analysis ensuring accuracy and validity of data.
• Conduct experiments, summarize results, and present recommendations to cross-functional teams including senior management.
• Lead MRB meetings and facilitate discussions.
• Initiate and lead CAPA documents (Deviations, NCMR, etc.).
• Establish direct report performance and development goals and provide feedback on performance.
• Identify process and product improvements using product data and metrics as a guide.
• Develop, revise and implement SOPs, Test Records, and product specification documents.

Skills

Protein-based immunoassays

Immunoassay troubleshooting

Statistical analysis

Laboratory safety

Design of Experiments (DOE)

Cross-functional leadership

Documentation & SOP development

Data visualization & interpretation

Communication skills

MS Office proficiency

Data analysis tools

Statistical software (MATLAB/MiniTAB)

Education

Bachelor's degree in a relevant field

Tools

MATLAB

MINITAB

Job description

POSITION SUMMARY:

An Associate Quality Scientist is responsible for independently managing the testing, technical transfer, and troubleshooting of protein-based immunoassays. An Associate Quality Scientist will play a critical role in addressing failing product, documenting failures appropriately and determining an appropriate path forward. This position may supervise the work of others directly and/or across interdisciplinary teams.

DUTIES AND RESPONSIBILITIES:

• 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.
• Conduct experiments, summarize results, and present recommendations to cross-functional teams including senior management.
• 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.).
• Establishes and monitors direct report performance and development goals, assigns accountabilities, sets objectives, establishes priorities, and provides 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 Standard Operating Procedures (SOPs), Test Records, and product specification documents, as required.
• Participate in general lab organization including inventory and equipment management and support 5S compliance.
• Ensure application of laboratory safety precautions and proper use of personal protective equipment.
• Specific duties may vary based on departmental requirements.

EXPERIENCE AND QUALIFICATIONS:

• Bachelor's degree and 2 years of experience in relevant field is required.
• o Additional education may be substituted for experience.
• o Additional experience may be substituted for degree.

KNOWLEDGE, SKILLS AND ABILITIES:

• Strong understanding of protein-based immunoassays and technique.
• Knowledge of protein-based immunoassays execution, development, and optimization is preferred.
• Knowledge of laboratory safety precautions and proper use of personal protective equipment.
• Ability to troubleshoot immunoassays and reagents using logical problem solving and root cause analysis.
• o Knowledge of Design of Experiments (DOE) is preferred.
• o Execute solutions to improve product performance and articulate solutions to broad cross-functional teams.
• Demonstrated aptitude for learning and applying new techniques and methodologies.
• Understanding of basic molecular biology techniques and their application.
• Leadership skills with demonstrated knowledge and understanding of staff management practices and processes. Ability to establish accountabilities and expectations and manage performance to achieve results
• 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.
• o Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data.
• Proficiency in MS Office suite.
• o Basic 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 $67,900 to $101,000. 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.

Bachelors (preferred)

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.