Bioanalytical Scientist

MESO SCALE DIAGNOSTICS, LLC.•Gaithersburg, MD

4h•$101,400 - $154,700•Hybrid

About The Position

The 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 sample analysis and validation 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 may directly supervise the work of others.

Requirements

Minimum of 4 years of hands-on laboratory work experience is required; experience in biological sample testing is 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 highly preferred
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/fast-paced lab is required

Nice To Haves

Ph.D. in Biology, Chemistry, or related scientific discipline preferred
Additional postdoctoral or industrial experience preferred
Master’s degree may be considered with additional years of related experience
Bachelor’s degree may be considered with additional years of experience including a minimum of 4 years of hands-on experience with the MSD platform
Supervisory/management experience desired

Responsibilities

Manage sample analysis and method validation projects performed 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
Review documentation associated with executed projects including data capture, forms, logbooks, and inventory batch records
Provide technical guidance 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
Review lot qualification data
Monitor material inventory, project-specific materials in particular, to ensure no impediments in completing studies.
Draft appropriate study plans, reports, and documents
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
If applicable, establish and monitor direct report performance and development goals, assign accountabilities, set objectives, and provide continuous feedback and recognition on performance
May be responsible for training and development of laboratory team