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Senior Bioanalytical Scientist
2 months ago
Meso Scale Discovery is seeking a highly experienced and skilled Senior Bioanalytical Scientist to join our team. As a key member of our bioanalytical laboratory, you will be responsible for providing technical guidance and expertise in executing sample analysis studies and analytical method validations.
Key Responsibilities- Manage multiple sample analysis and method validation projects concurrently in the bioanalytical laboratory, ensuring compliance with Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP) regulations.
- Plan and oversee individual experiments as required for each project, ensuring the availability of necessary resources and equipment.
- 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, promoting the execution of bioanalytical projects and adherence to GLP/GCLP best practices.
- Lead and/or support the implementation of process improvements in support of laboratory initiatives and strategies.
- Interpret, organize, and present study results as required for each project, ensuring accuracy and validity.
- Oversee/mentor more junior team members in the interpretation, organization, and presentation of study results.
- Verify the accuracy and validity of data, ensuring 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.
- 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 personal protective equipment (PPE), and monitor the behavior of laboratory staff to 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 personnel.
- 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.
- 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.
