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Job: Chemist/Study Director, IR-4 Project, Raleigh, NC

General Information

Job title:
Chemist/Study Director
Job location:
Raleigh, NC  27606 United States
Requisition code:
Date posted:
Commensurate with Experience ($80,000 - $95,000)
Job category:
Agricultural Biotechnology
Employment type:
Full time

Job Description

About the Department
The IR-4 Project is a national Federal/State partnership research program to assist farmers of fruits, vegetables, nuts, herbs, ornamentals, and other specialty crops by facilitating registration of safe and effective chemical and bio-based pest management products. The IR-4 Project is needed because the crop protection industry focuses its research efforts on major crops such as corn, soybean, and cotton that provide the companies adequate return on their development investment.

Without IR-4, farmers of specialty crops would only have access to a few crop protection products to protect their crops. IR-4 Project Headquarters provides national leadership, coordination, and regulatory compliance for the IR-4 Project research activities performed by approx. 125 scientists at over 20 public sector research farms and five analytical laboratories throughout the United States.

Essential Job Duties
The Study Director position will report directly to the IR-4 Associate Director for Regulatory Sciences. This position will be an integral part of the IR-4 Unit. Duties of this position include, but are not limited to:

Independent Project Development (15%):
Provide technical direction of IR-4 Magnitude of the Residue Studies that are performed by the cooperating university and government scientists at various locations throughout North America. All aspects of the study must follow the provisions of the United States Environmental Protection Agency’s Federal Good Laboratory Practice (Chapter 40- Code of Federal Regulations, Part 160) regulations. Specific duties include development of approx. 10 national research protocols (study plans) annually for IR-4 Project sanctioned studies. Responsible for drafting and developing protocols after extensive consultation with owners of the products, study scientists, and IR-4 Project biologists. Must be able to balance the needs of stakeholder suggestions in the development of the final product. Protocols must be prepared and authorized well in advance of target dates for research.

Project Coordination (20%):
Direct and manage approx. 20 on-going IR-4 sponsored residue studies in various phases of completion. An average IR-4 residue study involves seven field trials and one analytical phase performed at various research facilities. This means that the Study Director is responsible to direct the research of 160 research projects. As autonomous director of the projects, she/he must assist scientists to successfully plan, conduct and report on IR-4 sponsored research with chemical and bio-based pesticides on specialty crops. Must promptly evaluate and approve all proposed modifications from the authorized research protocol. Must keep track of the status of active studies, including knowledge when critical phases of research are planned/performed, when residue samples are shipped to the analytical laboratory, when samples are analyzed by the laboratory and when research reports are received. Communicate with numerous individuals to maintain involvement in all facets of the research. Also responsible to critically review and scientifically assess the data/data reports associated with the studies in a timely manner to ensure that the research was performed appropriately and according to protocol. The review includes the test substance application rates, application timing of the test substance collection of adequate residue samples, and appropriate storage of samples before and during shipping to the laboratory, review of the analytical data including the analytical summary report. All findings of the Quality Assurance unit must be promptly addressed.

Data Package Development (30%):
Independently develop approx. 10 “submission ready” data packages annually utilizing established national (USEPA-OPPTS GUIDELINES) and/or international standards (e.g. UN FAO-Joint Meeting on Pesticide Residues). Expectations are that the incumbent:

• Prepare quality reports that are easily reviewed by all parties (Quality Assurance Unit, IR-4 Management, Cooperating Company, US EPA, others). When something is missing, identify the gap, solicit information and/or data for performing facilities in order to close data gaps, then compose summaries and existing data/info in the correct format. This must be completed under IR-4 established timelines.
• Maximize the value of existing research through the use of extrapolation models and crop groups, reduced data requirement proposals, and/or broad use patterns. Communicate with personnel in all facets of the project in a professional manner to complete projects in accordance with timelines.
• Assist other Study Directors in preparing reports and interpreting data.

Chemist (25%):
Maintain up-to-date analytical information for others, effectively evaluate analytical data and provide analytical support for other IR-4 staff.

• Review analytical data, provide suggestions to address issues and respond to chemistry questions effectively. Provide support and coaching on chemistry questions to other scientists who may not have a chemistry background.
• Provide support to IR-4 Regional/ARS Laboratories. Negotiate with laboratory directors when needed, to best meet both the chemistry and regulatory needs for a study.
• Assist in the review of all protocols with regard to analytical chemistry. Contact registrants to provide access to current analytical methods for IR-4 projects and maintain chemistry library and edocs collection of analytical methods and COAs.
• Prepare information and solicit bids from contract research organizations. Organize comparison bids to assist in approval process.

Other responsibilities as assigned (10%):
Attend IR-4, grower, and professional meetings, make presentations and join committees of appropriate groups. Assist other Study Directors and Senior Study Director & Scheduling Manager in the completion of projects. Work in a cooperative manner with other individuals at Headquarters and elsewhere. General duties at IR-4 Headquarters include maintaining support for the office and research programs.

Other Responsibilities
Perform other related duties as assigned.

Job Requirements

Master of Science or Ph.D. degree in chemistry with specializations and/or skills in analytical chemistry, and at least 3 years of experience in pest management research/regulatory sciences; or Bachelor of Science degree and at least 10 years’ experience in chemistry.

Other Required Qualifications
Ability to maintain attention to detail, prioritize and meet deadlines. Excellent oral, written, and interpersonal skills.
Documented training and experience with U.S. Environmental Protection Agency Good Laboratory Practice Regulations and independent project directorship.

Required License(s) or Certification(s)
Valid NC driver’s license or the ability to obtain with 60 days of start. Driver’s license needed to travel to various meetings in state and nationally.

*Submit your application at this website:
(Job number: 4052977)
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