Senior Associate Scientist, Bioanalytical Lab

MESO SCALE DIAGNOSTICS, LLC.•Gaithersburg, MD

8d•$88,100 - $134,400•Onsite

About The Position

The Senior Associate Scientist, Bioanalytical Laboratory supervises daily laboratory operations and provides guidance and direction to laboratory team members to ensure on-time completion of customer projects. This includes the transfer and qualification/validation of newly developed assays, reagents and/or instruments intended for use in sample testing services that may be performed under regulatory compliance. This position may directly supervise the work of others and provide guidance to laboratory team.

Requirements

Bachelor’s degree in biology, chemistry, or other related scientific discipline 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

Nice To Haves

Master’s degree is preferred
Minimum of 6 years of hands-on work experience in biological sample testing or reagent/assay development in an industrial setting is preferred
experience in a clinical research organization (CRO) or other regulated environment is highly preferred; academic setting considered
Demonstrated proficiency in executing wide range of relevant assays can be substituted for up to 1 year of work experience
Experience with running immunoassays/ligand-binding assays is highly preferred
Experience with running assays on the MSD platform is highly preferred

Responsibilities

Supervise or independently execute studies performed in the Bioanalytical Laboratory in accordance with applicable study plans and standard operating procedures (SOPs)
Support laboratory team as needed to procure reagents and materials required for planned studies
Review documentation associated with executed projects including data capture, forms, logbooks, and inventory batch records
Assist team members with interpreting results and troubleshooting technical issues
Verify the accuracy and validity of data; correct any errors
Ensure that out-of-specification results or deviations from protocol are properly documented
Present bioanalytical principal investigators (BPIs) with summaries of troubleshooting efforts and conclusions
Supervise transfer and qualification/validation of newly developed or custom assays/platforms for routine testing in a regulated environment.
Adhere to all laboratory safety policies and procedures including proper use of all required personal protective equipment (PPE); monitor the behavior of others within the laboratory and provide guidance on best practices for laboratory safety
Adhere to principles of Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP) applicable to bioanalytical sample testing and analysis
This role may supervise the work of others in all aforementioned areas of productivity and effectiveness
Responsible for supporting, mentoring and documenting performance evaluations for those they supervise
May be responsible for training and development of laboratory team members