Bioanalytical Scientist

POSITION SUMMARY

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.

• 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 laboratorystaff
• 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

• 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
• 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
• Supervisory/management experience desired

• 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 ability to execute and oversee assays run in a fast‑paced environment with a focus on high‑quality results.
• Demonstrated ability to troubleshoot complex issues and provide solutions to technical challenges.
• Leadership skills with demonstrated knowledge and understanding of staff management practices and processes. Ability to establish accountabilities and expectations and manage performance to achieve results.
• Excellent interpersonal skills and ability to work well with employees at all…