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Advanced Clinical Testing Lead

Employer
Medical Science & Computing (MSC), a Dovel company
Location
Gaithersburg, Maryland
Start date
Jul 29, 2022

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Discipline
Clinical, Clinical Research, Clinical Testing/Monitoring
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
BioCapital
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Job Details

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.

 

Requirements
  • 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.

 

 

Company Description

Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.

 

Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.

 

Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

 

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance, including the Fair Chance Ordinance of Los Angeles and San Francisco.

 

If you have visited our website for information about employment opportunities or to apply for a position, and you require accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

 

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse, and Guidehouse will not be obligated to pay a placement fee.

 

 

Company

Medical Science & Computing (MSC), a Dovel company, is a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. The Dovel Family of Companies combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management. 

MSC has long supported Federal health organizations like the National Institutes of Health (NIH) and applies deep understanding of missions, goals, and operations to discover and implement innovative approaches for streamlining and disseminating research efforts, enhancing knowledge sharing, and improving public health. 

Together, Dovel and MSC offer a diverse set of complex biomedical, scientific, and technology services, coupled with attentive and purpose-driven program management to serve mission critical organizations and drive meaningful change in the world.

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Find Us
Website
Location
11300 Rockville Pike Suite 1100
Rockville
MD
20852
United States
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