Regulatory Affairs Toxicologist

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Position
Regulatory Affairs Toxicologist
Location Confidential
No
Location
No preference
Willing to Relocate
Yes
Industry
Agribusiness/Aquaculture-Fresh&FrozenFoods
Function
RiskManagement
Compensation
$100,000 to $200,000

Resume Summary
With 21 years of experience in regulatory toxicology, verifying or assisting in compliance with EPA statutes, I can get your products registered. Expertise includes: toxicity testing, data evaluation, risk/hazard assessment, statistical analysis, oral/written communication, negotiation, flexible (manage multiple projects).

Resume Body      REGULATORY AFFAIRS TOXICOLOGIST

PROFESSIONAL EXPERIENCE

2000-Present, Dynamac Corporation, Durham, NC (www. dynamac.com)
>Staff Toxicologist/Deputy Program Manager

* Promoted to Deputy Program Manager within 3 years of initial employment.
* Registration/re-registration submissions: Evaluated toxicity data submitted to the Antimicrobial and Health Effects Division of the Office of Pesticide Programs, EPA. Identified technical issues and data gaps. Wrote reports (over 388 to date) summarizing the studies, detailing toxicological endpoints, and determining the NOAEL and LOAEL doses when appropriate. Also responsible for technical oversight, review, and editing of assignments completed by co-workers (over 326 to date).
* Familiar with the OPPTS Series 870 test guidelines and OECD equivalents. Wrote and/or reviewed toxicity studies for almost all of these guidelines, such as combined chronic toxicity/carcinogenicity, developmental neurotoxicity, immunotoxicity, metabolism and pharmacokinetics, reproduction and fertility toxicity, prenatal developmental toxicity, and all genetic toxicity tests. Also wrote and reviewed non-guideline tests.
* Toxicity Endpoint Selection Reports: Selected the appropriate toxicological endpoints from pesticide toxicity study submissions and calculated Reference Doses in Toxicity Endpoint Selection Reports. This process is EPA’s hazard assessment, and this report replaced the Hazard Identification Assessment Review Committee (HIARC) reports.
* Participated in the OECD harmonization project.
* Performed work for the EPA’s Toxicological Reference Database, reviewing and entering data from at least 15 multigenerational reproduction and 42 developmental studies.
* Critically reviewed data and wrote reports for the Endocrine Disruption Program of the EPA. Also wrote the draft for the Standard Evaluation Procedure for the Androgen Receptor Binding Assay.
* Worked on the National Center For Environmental Assessment (NCEA) project, developing Provisional Toxicity Values (PTV) using modern risk assessment techniques in accordance with EPA guidelines. Also, performed literary search and summarized pertinent information for the derivation of the PTV.
* Orally communicated with EPA to discuss and sometimes to convince the personnel of the most defensible toxicological conclusion.

1989-2009, Enviro-Lab, Inc., Houma, LA
>Toxicologist/Laboratory Supervisor/Statistician

* Promoted to Laboratory Supervisor in less than a year of initial employment. Functioned as Statistician, remotely, after entering the graduate school toxicology program.
* Performed statistical analysis of test results in accordance with established EPA protocols, generating over 1200 reports.
* Orally communicated with the Louisiana Department of Environmental Quality and the EPA.
* Performed all aspects of aquatic bioassays, including industrial effluent sample collection, aquatic animal culture, and sample analysis and testing.

1999-2000, St. Jude Children’s Research Hospital, Department of Molecular Pharmacology
>Postdoctoral Research Associate.

* Discovered a potential target for glioblastoma therapy, PKC?.
* Used molecular biology techniques to identify the target.

1994-1999, University of Arkansas for Medical Sciences
>Graduate Student

* Fusarin C: Investigated the role of fusarin C as a suspected carcinogenic mycotoxin under the National Toxicology Program's (NTP) Fumonisin project at the National Center for Toxicological Research (NCTR, part of FDA).
* Performed literature search to identify data gaps and lack of data integrity regarding the genotoxicity of fusarin C.
* Grew fungi in solid and liquid cultures, and used many analytical biochemistry techniques to isolate and identify fusarin C and determine if fusarin C was genotoxic.
* Rodent husbandry: Familiar with rodent feeding, maintenance, and dissection technique.
* Performed data mining to determine any relationships that existed between toxic effect and the genotype and phenotype of treated rats. Evaluated biological endpoints, including both tumor incidence and the incidence of non-neoplastic lesions.

AWARDS/ACHIEVEMENTS
* Awarded merit salary raise each year at Dynamac
* Supervisors at Dynamac call me their most prolific writer, and EPA typically rates my reports as good or excellent
* Mensa member
* ORISE fellowship (1996-1999)
* UAMS fellowship (1994-1995)
* President’s List or Dean’s List all regular semesters
* Full tuition paid scholarship to Northeast Louisiana University (1985-1989)
* Distinguished College Student of America
* Alpha Epsilon Delta Honor Society
* Valedictorian of Fairview High School

EDUCATION
* Ph.D., Interdisciplinary Toxicology, University of Arkansas for Medical Sciences, Little Rock, AR, 1999
* B.S., Toxicology, Northeast Louisiana University, Monroe, LA, 1989

SPECIALTY/TECHNICAL COURSES
* Toxicological data review under OPPTS 870 Series Health Effects Test, EPA
* Review of developmental neurotoxicology studies under OPPTS 870 Series, EPA
* Pesticide risk assessment, NC State University, Dept. of Env. and Molecular Toxicology
* Electronic data submission, EPA
* Toxicology endpoint selection, EPA
* Selected other HED risk assessment training courses, EPA
* Radiation and laboratory safety at NCTR
* Microsoft Office programs at NCTR

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Regulatory Affairs Toxicologist

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