Senior Bioanalytical Scientist & Lab Leader (GLP/GCLP)

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

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.