Description Job Description
SAIC is seeking a Subject Matter Expert to support the research program of the FDA’s Center for Biologics Evaluation and Research, Office of Tissue and Advanced Therapies, Division of Plasma Protein Therapeutics (DPPT) with the goal to advance research through the use of the OriginPro based in-house software which is used for analysis of experimental data and potency calculation. The Subject Matter Expert will apply fundamental mathematical models/algorithms for application to ongoing scientific research projects, execute analytic, research and programming projects in a variety of environments, and perform applicable laboratory and/or scientific computing in biomedical research and bench work skills. Additional responsibilities are listed below.The ideal candidate will:
• Apply fundamental mathematical models/algorithms for application in ongoing scientific research projects.
• Execute analytic, research and programming projects in different (program) environments, including Visual Studio, OriginPro and MatLab.
• Perform C/C++ (and/or Origin C) programming language tasks and projects.
• Perform applicable laboratory and/or scientific computing in biomedical research and bench work skills, participate in the design and execution of research experiments, and the development of biological assays.
• Optimize existing biological assays for improved sensitivity and reproducibility.
• Independently plan experiments and process data in data analysis and graphing software.
• Review relevant/emerging literature to incorporate concepts, techniques and knowledge into the experimental work that is being conducted by the Office of Tissues and Advanced Therapies (OTAT).
• Review relevant/emerging literature to incorporate concepts, techniques and knowledge into the experimental work that is being conducted by OTAT.
• Create summaries of progress achieved in various projects – based on in-depth knowledge and/or background – for presentations at or from laboratory meetings and research conferences.
• Maintain thorough and complete government-owned records of dry-lab experiments, standard operating procedures (SOPs), and data in hard copy laboratory notebooks, as well as in electronic versions made available to the Principal Investigator and other individuals in the laboratory.
Qualifications TYPICAL EDUCATION AND EXPERIENCE:
• PhD in Cell/Cellular Molecular Biology or related scientific discipline is required.
• 5+ years laboratory experience, specifically research related to blood coagulation, drug safety and efficacy is preferred.
• Experience with software tools for specialized assay analysis, including Origin and Origin C.
• Expertise in regulated biologics products (human blood and blood products and Lentiviral based-gene therapy products for Hemophilia A) to develop new FDA standards and guidelines
• Familiarity with FDA regulatory process.
• Expertise in RNA-seq, microRNA-based biomarker development, Hematological assays, as well as multiple in-vitro and in-vivo systems to study viral RNA translation and replication
• Strong communication skills and ability to interact in a cross-functional environment.
SAIC is a premier technology integrator, solving our nation's most complex modernization and systems engineering challenges across the defense, space, federal civilian, and intelligence markets. Our robust portfolio of offerings includes high-end solutions in systems engineering and integration; enterprise IT, including cloud services; cyber; software; advanced analytics and simulation; and training. We are a team of 23,000 strong driven by mission, united purpose, and inspired by opportunity. Headquartered in Reston, Virginia, SAIC has annual revenues of approximately $6.5 billion. For more information, visit saic.com. For information on the benefits SAIC offers, see Working at SAIC. EOE AA M/F/Vet/Disability