Senior Scientist, Quality

Default (MSD); Rockville (MD); On-site; USD 88,000 - 134,000; Full time

Benefits offered by this job

Medical benefits

401(k) plan

Job summary

MSD in Rockville, MD seeks a Senior Quality Scientist to independently manage testing priorities, design experiments for troubleshooting and product performance, and mentor analysts. Responsibilities include technical transfer, CAPA approvals, and guiding project teams while ensuring compliance with ISO standards.

The role emphasizes MRB coordination, problem solving, and leadership in a fast-paced environment focused on protein-based immunoassays and product release readiness.

Qualifications

• Bachelor's degree in life sciences or related field required; PhD preferred.
• Experience leading small teams and driving quality in ISO/GMP settings.
• Experience with protein immunoassays, and molecular biology basics.
• Proven ability to manage multiple high-impact projects with timelines.

Responsibilities

• Manage troubleshooting of non-conforming products and high-impact projects.
• Direct testing, analyze data, review and approve results.
• Approve CAPA documents (NCMRs/DEVs) and MRB outcomes.
• Lead MRB meetings and coordinate cross-functional reviews.
• Mentor analysts and associate scientists in methods and DOE.
• Develop SOPs, test records, and product specs.
• Ensure documentation complies with ISO standards.
• Support 5S and continuous improvement initiatives.

Skills

Leadership

Problem solving

Technical troubleshooting

Documentation & ISO

Communication

Project management

Quality systems

Excel/Office

Education

Bachelor's degree in Life Sciences

PhD preferred

Tools

MS Office

Excel

SharePoint

Access

LIMS

Job description

Job Category: Quality - Control/Assur/Regul

Requisition Number: SENIO003929

Full-Time

Locations

Showing 1 location

Rockville, MD 20850, USA

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.
• 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.
• 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.

Qualifications

• Bachelors or better in Life Sciences 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.