Meso Scale Diagnostics, LLC.
Principal Bioanalytical Scientist
Meso Scale Diagnostics, LLC., Gaithersburg, Maryland, us, 20883
The Principal 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 also assist in identifying and implementing departmental initiatives and strategies and will directly supervise the work of others.
Key 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 Good Clinical Laboratory Practice (GCLP) as required. This role is expected to independently handle projects with high technical or logistical complexity.
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 as well as GLP/GCLP best practices.
Lead and/or support implementation of process improvements in support of laboratory initiatives and strategies.
Interpret, organize and present study results as required for each project.
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 more junior team members.
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.
Supervisory Responsibilities:
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 personnel.
Minimum Qualifications:
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.
Hands-on laboratory work experience running immunoassays/ligand-based assays is required.
Minimum of 10 years of overall work experience in positions of increasing responsibility is required; experience in biological sample testing is highly preferred; experience with the MSD platform is highly preferred; experience in a clinical research organization (CRO) or other regulated environment is highly preferred; academic setting considered.
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.
Minimum of four years of supervisory/mentoring/management experience is required.
Additional Skills:
Advanced understanding of ligand-binding assays.
Advanced level knowledge of GLP/GCLP principles as they apply to bioanalytical laboratories.
Demonstrated expertise in scientific principles and analytical thinking.
Demonstrated ability to work independently, analyze data and write reports.
Ability to effectively oversee assays run in a fast-paced environment with a focus on high-quality results.
Expert level ability with regards to troubleshooting technical issues and providing 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.
Proficiency in MS Office suite; familiarity 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.
Working Conditions:
This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office and laboratory.
This position is primarily performed in a traditional office environment.
Other assigned responsibilities will be performed in a laboratory environment up to 20% of the time, working with staff who are handling chemical reagents and performing some Biosafety Level 2 work.
May involve handling of BSL-2 materials and organisms including human blood and/or blood products.
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Key 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 Good Clinical Laboratory Practice (GCLP) as required. This role is expected to independently handle projects with high technical or logistical complexity.
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 as well as GLP/GCLP best practices.
Lead and/or support implementation of process improvements in support of laboratory initiatives and strategies.
Interpret, organize and present study results as required for each project.
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 more junior team members.
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.
Supervisory Responsibilities:
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 personnel.
Minimum Qualifications:
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.
Hands-on laboratory work experience running immunoassays/ligand-based assays is required.
Minimum of 10 years of overall work experience in positions of increasing responsibility is required; experience in biological sample testing is highly preferred; experience with the MSD platform is highly preferred; experience in a clinical research organization (CRO) or other regulated environment is highly preferred; academic setting considered.
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.
Minimum of four years of supervisory/mentoring/management experience is required.
Additional Skills:
Advanced understanding of ligand-binding assays.
Advanced level knowledge of GLP/GCLP principles as they apply to bioanalytical laboratories.
Demonstrated expertise in scientific principles and analytical thinking.
Demonstrated ability to work independently, analyze data and write reports.
Ability to effectively oversee assays run in a fast-paced environment with a focus on high-quality results.
Expert level ability with regards to troubleshooting technical issues and providing 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.
Proficiency in MS Office suite; familiarity 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.
Working Conditions:
This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office and laboratory.
This position is primarily performed in a traditional office environment.
Other assigned responsibilities will be performed in a laboratory environment up to 20% of the time, working with staff who are handling chemical reagents and performing some Biosafety Level 2 work.
May involve handling of BSL-2 materials and organisms including human blood and/or blood products.
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