Senior Bioanalytical Study Lead

Meso Scale Diagnostics LLC; Gaithersburg (MD); On-site; USD 67,900 - 101,000; Full time

Job summary

Meso Scale Diagnostics LLC is seeking a Senior Study Coordinator to support the Bioanalytical Laboratory in GLP/GCLP-compliant studies. You will assist BPIs, track timelines, and perform QC on study data, while managing multiple studies with meticulous documentation.

The role requires strong scientific background, effective communication, and ability to liaise across departments and with clients. Work is in an office environment with laboratory interaction as needed.

Qualifications

• Bachelor’s degree in biology, chemistry, or related scientific discipline, or equivalent work experience required.
• Master’s degree preferred.
• Experience in GLP/GCLP context is advantageous.

Responsibilities

• Drafts protocols, SAPs, amendments, reports and study schedules independently.
• Reviews records for compliance with SOPs, GLP/GCLP requirements.
• Communicates with other departments and clients on timelines and deliverables.

Skills

Scientific fundamentals

Communication skills

MS Office proficiency

Documentation & archiving

Education

Bachelor’s degree in biology/chemistry or related

Master’s degree preferred

Tools

MS Office

SharePoint

Job description

Meso Scale Diagnostics LLC is seeking a Senior Study Coordinator to support the Bioanalytical Laboratory in GLP/GCLP-compliant studies. You will assist BPIs, track timelines, and perform QC on study data, while managing multiple studies with meticulous documentation.

The role requires strong scientific background, effective communication, and ability to liaise across departments and with clients. Work is in an office environment with laboratory interaction as needed.