We are currently searching for an Advanced Clinical Testing Lead to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Gaithersburg, MD
Duties & Responsibilities
- Lead the advanced testing group, ensure QA and QC of work, provide technical review, direction, and feedback to others. Conduct advanced research. Design experimental approaches, provide critical evaluation of scientific data, mentor scientific staff and collaborates with other scientists and integration and start-up of new technologies within the laboratory.
- Establishment and implementation of electronic notebooks and integration with Laboratory Management Systems (LIMs) e.g. Freezerworks.
- Assess and implement levels of assay development required for phase 1 (first in human) to phase 3 according to Good Clinical Laboratory Practice (GCLP) and FDA guidelines.
- Coordinate advanced clinical testing of products developed from the program and partner organizations, such as the Bill and Melinda Gates Foundation.
- Coordination of US Government driven clinical trial immune assays e.g. from Countermeasures Acceleration Group (CAG) – formerly Operation warp speed.
- Strategize with leadership for the implementation Pandemic Preparedness measures and surge testing capabilities.
- Contribute to the project teams, responsible for supporting the assessment of biologics used for assay development and participating in strategic research that leads to innovation in a research environment.
- Plan delivery of results to industry partners according to data transfer agreements.
- Design and conduct experiments leading to the development and implementation of new or improved immunological methodologies. Leads project aspects to accomplish established milestones.
- Represent the program in various departmental and interdepartmental committees that address scientific goals of the program and new initiatives.
- Perform financial planning and budgetary management of reagents requirements.
- Transfer relevant immunoassays in a standardized form for high throughput automated testing.
- Build a capacity to automate standard assays for the program and develop immunology capability to ensure high throughput analyses of clinical trials.
- Maintain sample repositories.
- Coordinate effectively within a diverse and stratified team environment.
- Ph.D. in a scientific field is required.
- Minimum of five (5) years of specialized experience, preferably in a Clinical Research Organization (CRO).
- Conversant with FDA regulatory guidelines surround phase 3 testing and assay validation.
- Detailed knowledge of GCLP or GLP in the context of clinical trial analyses.
- Knowledge of implementing automated work flows for high throughout analyses.
- Knowledge of virus neutralization and binding antibody analyses.
- Demonstrates expert knowledge working in the research laboratory environment.
- Demonstrates expertise with laboratory assay and product development automation technologies.
- Computer skills to include MS Office Suite.
Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.
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