Will provide day to day oversight of laboratory operations and provision quality assurance oversight of the following:
Validation and implementation of FDA approved/cleared assays/platforms;
Laboratory Developed Assays;
Pre-Market Application clinical trials for FDA clearance/approvals;
Regulated laboratory support for Phase 1 safety; Phase II vaccine; therapeutic; and or cure trials;
Beta evaluations of new/novel products for HIV; sexually transmitted infections; blood borne infections; parasitology (Leishmania/malaria); and pathogens of US Military and US National interest per CAP/CLIA/CLIP and FDA regulatory requirements.
Bachelors Degree in medical technology; laboratory sciences; biological sciences or related discipline.
Graduate degree preferred.
5-7 years of documented experience in laboratory supervisory role
Documented experience in oversight of a CAP; CLIA/CLIP and/or FDA regulated lab.
Documented experience in quality assurance.
As a trusted systems integrator for more than 50 years, General Dynamics Information Technology provides information technology (IT), systems engineering, professional services and simulation and training to customers in the defense, federal civilian government, health, homeland security, intelligence, state and local government and commercial sectors.With approximately 32,000 professionals worldwide, the company delivers IT enterprise solutions, manages large-scale, mission-critical IT programs and provides mission support services.GDIT is an Equal Opportunity/Affirmative Action Employer - Minorities/Females/Protected Veterans/Individuals with Disabilities.
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