Overview

We are seeking aSenior Scientist to support the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a team focused on positively impacting millions of lives around the world. Candidates will work at a diverse and vibrant NIAID worksite to directly support ongoing research activities as a contractor team member. Take the next big step in your career and apply below to help us make a difference.

CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today’s most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs.

Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

Responsibilities

• Assist 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.
• Establish and implement 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.
• Coordinate US Government driven clinical trial immune assays e.g., from Countermeasures Acceleration Group (CAG) – formerly Operation warp speed.
• Provide assistance to the Vaccine Immunology Program 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. Meet project aspects to accomplish established milestones.
• Represent the Vaccine Immunology Program in various departmental and interdepartmental committees that address scientific goals of the program and new initiatives.
• 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.

Qualifications

• 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 workflows 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.

CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at www.CAMRIS.com. CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.

Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.