Senior Bioanalytical Scientist

MESO SCALE DIAGNOSTICS, LLC.•Gaithersburg, MD

3d•$116,600 - $177,800•Hybrid

About The Position

The Senior 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 multiple 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 will directly supervise the work of others.

Requirements

Minimum of 6 years of hands-on laboratory work experience is required
Minimum of 8 years of overall experience in positions of increasing responsibility is required; experience in biological sample testing is highly 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 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
Minimum of two years of supervisory/mentoring/management experience is required
Strong understanding of ligand-binding assays
Strong scientific fundamentals and analytical background
Demonstrated ability for logical problem solving and initiation, organization and implementation of process improvement activities
Demonstrated ability to oversee analytical testing with a focus on high-quality results.
Demonstrated ability to troubleshoot technical issues and provide solutions to complex problems.
Effective leadership skills with demonstrated knowledge and understanding of staff management practices and processes and the ability to establish accountabilities and expectations and manage performance to achieve results
Excellent interpersonal skills and ability to work well with employees at all levels
Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data
Effectively communicate performance goals and expectations
Proficiency in MS Office suite; familiar with electronic file management using SharePoint (end user minimum)
Excellent organizational, planning, and time management skills with the ability to manage multiple and often changing priorities and issues of varying complexity, while meeting time-sensitive deadlines and deliverables
Intermediate level statistical knowledge

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 a minimum of 3 additional years of related experience
Bachelor’s degree may be considered with additional years of experience including a minimum of 6 years of hands-on experience with the MSD platform

Responsibilities

Manage multiple sample analysis and method validation projects concurrently 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
Approve documentation associated with executed projects including data analysis and reporting
Provide technical guidance and mentoring 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
This role may also oversee/mentor more junior team members in the interpretation, organization, and presentation of study results
Verify the accuracy and validity of data
Ensure that out-of-specification results or deviations from protocol are properly documented
Present summaries of troubleshooting efforts and proposed solutions/conclusions to laboratory management and other BAL scientific staff
Review lot qualification data
Monitor material inventory, project-specific materials in particular, to ensure no impediments to completing studies.
Draft appropriate study plans, reports, and documents and review project-related documentation generated by others
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
Establish and monitor direct report performance and development goals, assign accountabilities, set objectives, and provide continuous feedback and recognition on performance
Responsible for training and development of laboratory team