Senior Bioanalytical Scientist

Meso Scale Diagnostics LLC; Gaithersburg (MD); On-site; USD 117,000 - 178,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) plan with company matching

Paid vacation, sick leave, holidays, &

Paid parental leave

Employee assistance program

Fitness club membership contribution

Pet insurance

Identity theft protection

Home and auto insurance discounts

Optional supplemental life insurance

Job summary

Meso Scale Diagnostics LLC in Gaithersburg, MD, seeks a Senior Bioanalytical Scientist to lead and oversee complex immunoassay studies and method validations in a GLP/GCLP environment. You will supervise staff, manage project timelines, and interact with customers to ensure studies meet regulatory requirements.

The role requires a Ph.D. or equivalent, extensive lab experience, and strong leadership, data analysis, and problem-solving skills.

Qualifications

• Ph.D. in Biology, Chemistry, or related discipline preferred.
• Postdoctoral or industrial experience preferred.
• Master's degree may be considered with 3+ years of related experience.
• Bachelor's degree may be considered with additional years of experience, including 6+ years hands-on MSD platform.
• Minimum 6 years hands-on laboratory work experience required.
• Minimum 8 years overall experience in roles of increasing responsibility; CRO or regulated environment preferred.
• Experience running immunoassays/ligand-binding assays required.
• Experience running assays on the MSD platform required.
• BSL-2 techniques training/experience required.
• GLP/GCLP training/experience required.
• Experience in high-complexity/high-throughput lab required.
• Minimum 2 years supervisory/mentoring/management experience required.

Responsibilities

• Manage multiple sample analysis and method validation projects concurrently in the Bioanalytical Laboratory.
• Plan and oversee individual experiments for each project.
• Ensure resources (reagents, materials, equipment) are available for staff.
• Approve documentation including data analysis and reporting.
• Provide technical guidance and mentoring to staff as needed.
• Interpret, organize and present study results for each project.
• This role may oversee/mentor junior team members in data interpretation and presentation.
• Verify the accuracy and validity of data.
• Document out-of-spec results or deviations from protocol.
• Present summaries of troubleshooting efforts and proposed solutions to management.
• Review lot qualification data.
• Monitor material inventory to prevent impediments to studies.
• Draft study plans, reports, and project documents.
• Review analytical reports for completeness and compliance.
• Adhere to GLP/GCLP principles in bioanalytical testing.
• Adhere to safety policies and PPE requirements.
• Set objectives and provide feedback on performance.
• Train and develop laboratory team.

Skills

Ligand-binding assays

Analytical leadership

GLP/GCLP knowledge

Supervisory experience

Problem solving

Communication skills

MS Office & SharePoint

Data analysis & reporting

Laboratory safety

High-throughput lab experience

Education

Ph.D. in Biology/Chemistry or related field

Postdoctoral or industrial experience preferred

Master's degree with 3+ years related experience

Bachelor's degree with 6+ years MSD platform experience

Tools

MS Office

SharePoint

Job description

POSITION SUMMARY

The Senior Bioanalytical Scientist functions as a Bioanalytical Principal Investigator (BPI), providing technical guidance and expertise in executing sample analysis studies and analytical method validations. This includes managing multiple projects, overseeing the analytical schedule in coordination with laboratory management, and providing guidance to bioanalytical testing staff and other team members as needed. This role will interact with customers to ensure the studies are managed under the appropriate regulatory scope, review study data, and conduct applicable data analysis as required by each project. This position will directly supervise the work of others.

DUTIES AND RESPONSIBILITIES

• Manage multiple sample analysis and method validation projects concurrently in the Bioanalytical Laboratory utilizing appropriate protocols and in compliance with Good Laboratory Practice (GLP)and/or Good Clinical Laboratory Practice (GCLP) as required
• Plan and oversee individual experiments as required for each project
• Ensure resources (reagents, materials, equipment) are available and appropriate for intended use by laboratory staff
• Approve documentation associated with executed projects including data analysis and reporting
• Provide technical guidance and mentoring to bioanalytical testing staff and other team members as needed in the execution of bioanalytical projects
• Interpret, organize and present study results as required for each project
• This role may also oversee/mentor more junior team members in the interpretation, organization, and presentation of study results
• Verify the accuracy and validity of data
• Ensure that out-of-specification results or deviations from protocol are properly documented
• Present summaries of troubleshooting efforts and proposed solutions/conclusions to laboratory management and other BAL scientific staff
• Review lot qualification data
• Monitor material inventory, project-specific materials in particular, to ensure no impediments to completing studies.
• Draft appropriate study plans, reports, and documents and review project-related documentation generated by others
• Review analytical reports for completeness and compliance with study requirements
• Adhere to principles of GLP/GCLP applicable to bioanalytical sample testing, data analysis and reporting
• Adhere to all laboratory safety policies and procedures including proper use of all required personal protective equipment (PPE); monitor the behavior of laboratory staff and proactively address departures from best practices for laboratory safety
• Establish and monitor direct report performance and development goals, assign accountabilities, set objectives, and provide continuous feedback and recognition on performance
• Responsible for training and development of laboratory team

EXPERIENCE AND QUALIFICATIONS

• Ph.D. in Biology, Chemistry, or related scientific discipline preferred
• Additional postdoctoral or industrial experience preferred
• Master's degree may be considered with a minimum of 3 additional years of related experience
• Bachelor's degree may be considered with additional years of experience including a minimum of 6 years of hands‑on experience with the MSD platform
• Minimum of 6 years of hands‑on laboratory work experience is required
• Minimum of 8 years of overall experience in positions of increasing responsibility is required; experience in biological sample testing is highly preferred; experience in a clinical research organization (CRO) or other regulated environment is highly preferred; academic setting considered
• Experience with running immunoassays/ligand-binding assays is required
• Experience with running assays on the MSD platform is required
• Training in and experience with Biosafety Level 2 (BSL-2) techniques is required
• Training in and experience with GLP and/or GCLP is required
• Experience working in a high complexity/high throughput lab is required
• Minimum of two years of supervisory/mentoring/management experience is required

KNOWLEDGE, SKILLS AND ABILITIES

• Strong understanding of ligand-binding assays
• Strong scientific fundamentals and analytical background
• Demonstrated ability for logical problem solving and initiation, organization and implementation of process improvement activities
• Demonstrated ability to oversee analytical testing with a focus on high-quality results.
• Demonstrated ability to troubleshoot technical issues and provide solutions to complex problems.
• Effective 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
• Excellent interpersonal skills and ability to work well with employees at all levels
• Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data
• Effectively communicate performance goals and expectations
• Proficiency in MS Office suite; familiar with electronic file management using SharePoint (end user minimum)
• 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
• Intermediate level statistical knowledge

PHYSICAL DEMANDS

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

WORK ENVIRONMENT

• This position is primarily performed in a traditional office environment
• Other assigned responsibilities will be performed in a laboratory environment up to 20% of the time, working with staff who are handling chemical reagents and performing some Biosafety Level 2 work
• May involve handling of BSL-2 materials and organisms including human blood and/or blood products

COMPENSATION SUMMARY

The annual base salary for this position ranges from $116,600 to $177,800. 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.

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.