Interdisciplinary:

Research Molecular Biologist series 401;

Research Chemist (Biochemistry) series 1320; and

Research Molecular Geneticist series 440\
GS-11

Factor I. Research Assignment

A. Assigned Responsibility

This Research Molecular Biologist is assigned to the Foodborne
Contaminants Research Unit, Western Regional Research Center, USDA ARS,
Albany, California. Projects are organized under CRIS 5325-320-043-00D,
"Development of detection technologies for toxins and their validation
in food matrices," under National Program 108 Food Safety. Performs
individual and team research to develop antibodies used in detection of
biothreat toxins in foods. Projects include both fundamental and applied
research topics. Collaborates with other scientists at the Location,
within ARS, nationally, and internationally, as needed, to acquire
critical expertise and materials.

B. Research Objectives and Methodology

This position requires creativity and latitude in methodology, but is
generally focused on detection of toxins or surrogates in complex food
samples using newly developed antibodies against *Clostridium botulinum*
neurotoxin (BoNT). Methodology includes experimental animal
immunizations using gene fragments and low-toxicity toxin protein
fragments. Incumbent will develop novel antibody-secreting hybridoma
cell lines and characterize monoclonal antibodies for incorporation into
high-tech assay platforms. Assay technology might include nanoparticles,
microfluidics, evanescent waves, high-content screening, or single
molecule detection.

C. Expected Results

The goal of this research is the development of new techniques for
specific detection of BoNT and/or other substances (surrogates)
indicating the presence of BoNT. These techniques will have direct
application in monitoring foods and will result in improved food safety
and security for the U.S. food supply. Technology transfer will be
achieved by publication of results in the peer-reviewed scientific
literature or US Patents and Trademarks. The results will thus
contribute to Goal 3 of the ARS Strategic Plan: Enhance Protection and
Safety of the Nation's Agriculture and Food Supply.

D. Knowledge Required

The employee exercises a broad understanding of molecular biology and
biochemistry. Specifically, the assignment requires knowledge of cloning
and expression of bacterial genes, to produce milligram quantities of
DNA and recombinant protein fragments. Skills in organization and
teamwork are required to ensure successful completion of this
multidisciplinary research project.

E. Supervisory Responsibilities

Provides technical supervision over one Biological Science Laboratory
Technician, GS-5, -6, or -7. Provides guidance on procedures and methods
to be employed, reviews work in progress.

Factor II. Supervision Received

A. Assigned Authority

This position includes responsibility for planning and conducting
experiments relevant to Unit programs. Changes in experimental design or
protocols, other than minor technical adjustments, require approval by
the Supervisor. Responsible for appropriate recording, interpretation,
and reporting of research.

B. Technical Guidance Received

This individual is an expert laboratory scientist, and will identify and
obtain any necessary additional resources, including personal assistance
and training. The scientist works effectively with minimal technical
supervision. Planning and organizing experiments within the overall
research program of the laboratory and the Unit are coordinated through
the Supervisor.

C. Review of Results

This employee is responsible for executing, analyzing, interpreting, and
reporting personal research. Work will be technically accurate, and
interpretation will be scientifically sound. Reports will be reviewed by
the Supervisor, prior to review under USDA Dual-Use policy, and
subsequent evaluation and validation by the scientific community.

D. General Supervision

This employee works under the general supervision of a Category 1
scientist. Guidance and feedback are provided via e-mail, telephone, and
personal meetings. Coordination includes sharing data and experimental
observations, as well as interpretation and plans for future
experiments. Changes in experimental design or protocols, other than
minor technical adjustments, require approval by the Supervisor.
Coordination with personnel and other necessary resources outside the
Unit is managed through the Supervisor.

Factor III. Guidelines and Originality

A. Available Literature

Much literature is available on the detection of biothreat toxins and on
the biochemistry and molecular biology of *Clostridium botulinum* and
BoNT, but few available antibodies exhibit tight binding, which is
necessary for maximum immunoassay sensitivity. Protocols for
experimental immunization using genes and gene fragments are available,
although the technique must be optimized for new target antigens.
Methods are available for general expression and purification of cloned
DNA and recombinant protein fragments, although production of milligram
quantities of soluble material will provide challenges.

B. Originality Required

Creativity is required to identify appropriate published methods and
adapt them for new research applications. Originality is necessary for
discovery and characterization of new and useful detection technologies
and study of matrix effects. Novel hypotheses must be tested because
incremental advances in toxin assay have not provided adequate detection
technology. Sample preparation strategies for complex food samples are
required to be effective in removing inhibitors of PCR reactions, for
example, but must be rapid and, in some cases, portable.