Senior Associate Scientist, Bioanalytical Lab

Senior Associate Scientist, Bioanalytical Lab

Job Category: Quality - Control/Assur/Regul

Requisition Number: SENIO
003895

• Posted :
  September 16, 2026
• Full-Time

Showing 1 location

Gaithersburg, Maryland
Gaithersburg, MD 20877, USA

POSITION SUMMARY:

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.

DUTIES AND 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

EXPERIENCE AND QUALIFICATIONS:

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

KNOWLEDGE, SKILLS AND ABILITIES:

• Strong understanding of ligand‑binding assays
• Strong scientific fundamentals and analytical background
• Logical problem solving and demonstrated ability to initiate, organize and implement process improvement activities
• Demonstrated understanding and ability to execute and oversee assays run in a fast‑paced environment with a focus on high‑quality results.
• Ability to troubleshoot issues and provide solutions to technical challenges.
• Excellent interpersonal skills…