Senior Scientist, Quality

Meso Scale Diagnostics LLC; Rockville (MD); On-site; USD 88,000 - 134,000; Full time

Job summary

Meso Scale Diagnostics LLC in Rockville, MD, seeks a Senior Quality Scientist to independently manage testing priorities, design experiments, and mentor analysts on troubleshooting and experimental design for protein-based immunoassays.

You will lead CAPA and MRB activities, review data, ensure ISO/GMP compliance, and support product release. The role requires strong leadership, the ability to manage multiple projects, and a proactive approach to quality improvement.

Qualifications

• Bachelor's degree in life sciences or related field required; PhD preferred.
• Minimum of 6 years of industrial reagent, product, or assay development experience.
• BSL-2 techniques experience highly preferred.
• Experience with ISO/GMP quality systems preferred.

Responsibilities

• Troubleshoot non-conforming products and manage multiple high-impact projects to improve product and process quality.
• Direct testing, analyze data, review and approve results and conclusions of others in the group.
• Approve CAPA documents, such as NCMRs and DEVs; approve MRB results.
• Review and approve presentations of junior level analysts and scientists in the group.
• Lead MRB meetings and present to cross-functional and/or senior management teams.
• Develop, revise, approve and implement SOPs/Test Records/product specification documents.

Skills

Leadership

Experiment design

Troubleshooting

Data analysis

Protein immunoassays

Molecular biology basics

Communication skills

MS Office

Team coaching

Education

Bachelor's degree in life sciences/related field

PhD preferred

Tools

SharePoint

Excel

Quality document systems

Job description

POSITION SUMMARY

A Senior Quality Scientist is responsible for independently managing testing priorities, design of experiments for troubleshooting and trending product performance, technical transfer, mentoring and training analysts and associate scientists on troubleshooting techniques and experimental design, advanced troubleshooting of protein-based immunoassays, and approving disposition status for materials under investigation. This may include responsibilities for product release. The incumbent is expected to display a wide-degree of latitude, creativity, and self-management and to be able to independently manage multiple projects in addition to providing oversight and guidance to other team members as needed.

DUTIES AND RESPONSIBILITIES

• Manage the process of troubleshooting non-conforming products and/or independently manage multiple high-impact projects to improve product and process quality.
• Direct testing, analyze data, review and approve results and conclusions of others in the group.
• Approve CAPA documents, such as NCMRs and DEVs.
• Approve results and conclusions from MRB meetings.
• Review and approve presentations of junior level associate scientists and analysts in the group.
• Plan testing, analyze data and present that data clearly.
• Review corresponding documentation for completion including data capture, forms, logbooks, and/or batch records.
• Ensure documentation is in compliance with applicable ISO standards.
• Create, coordinate and/or be the Technical Lead of any CAPA documents, such as NCMRs and DEVs.
• Coordinate and lead MRB meetings.
• Ensure proper handling, quarantine and disposition of discrepant material.
• Present to cross-functional and/or senior management teams.
• Prepare performance summaries and present results to colleagues.
• May manage, coach and develop team members while motivating them to meet and exceed goals. Promote a culture of high performance and continuous improvement that values learning and a commitment to quality.
• Participate in general lab organization.
• Support 5S compliance.
• Develop, revise, approve and implement SOPs/ Test Records/ and product specification documents.
• Specific duties may vary depending upon departmental requirements.

EXPERIENCE AND QUALIFICATIONS

• Bachelor's degree in life sciences, protein sciences, cellular/molecular biology, chemistry, biochemistry, biotechnology, or other related area is required.
• PhD is preferred
• Minimum of 6 years of experience in reagent, product or assay development in an industrial setting is preferred.
• Training and experience with Biosafety Level 2 (BSL-2) techniques is highly preferred.
• Experience with quality document systems in an ISO/GMP regulated environment preferred.
• Must have proven leadership of small teams coupled with an effective management style, as well as proven success at motivating personnel in a fast paced, priority driven environment.

KNOWLEDGE, SKILLS AND ABILITIES

• Demonstrated aptitude for learning and applying new techniques and methods
• Understand laboratory safety precautions and proper use of personal protective equipment.
• Strong 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.
• Experience with protein based immunoassays execution, development, and optimization
• Understanding of basic molecular biology techniques
• Logical problem solving and the ability to manage complex projects and meet timely deadlines
• Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data
• Effectively communicate performance goals and expectations
• Provide coaching and facilitate problem solving methodologies to team
• Proficiency in MS Office suite
• Experience with standard data analysis tools and databases (Excel, Access, SharePoint)
• The ability to multi-task and work productively in a demanding environment with changing priorities
• Effectively contributes to the success of departmental and team objectives - works well with personnel at all levels

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.

COMPENSATION SUMMARY

The annual base salary for this position ranges from $88,100 to $134,400. 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.

EDUCATION

Bachelors of Life Sciences (required)

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.