Job Summary

Battelle’s Life Science Research Center offers a staff of highly trained scientist and technicians, and state of the art facilities to support our clients’ toxicology, safety pharmacology, and inhalation research programs. Our multidisciplinary integrated approach to providing critical solutions for our pharmaceuticals, biotech, agrichemical, industrial, and government clients increases the speed of the development while maintaining quality and compliance.

The Toxicologist functions as a subject matter expert within the organization and, as a study director, has oversight of the scientific elements of projects to ensure successful implementation and/or study completion of toxicology studies. This position analyzes and reports results for publication or to sponsor, provides scientific instruction to other members of the project team, and collaborates with other senior members of the staff on projects/research.

This position is responsible for the organization, management, and business performance of non-clinical toxicology studies. Develops and implements strategic business and market plans which contribute to the group’s overall operating results through financial management of gross business volume, capital equipment and operating budgets.

Responsibilities

• Performs role of Toxicology Scientific Subject Matter Expert (SME) on commercial or government contracts and grants; interfaces with client's scientific staff as appropriate.
• Serves as Study Director on toxicology, biodistribution, pharmacokinetic, and related studies for commercial and government sponsors.
• Reviews toxicology data and authors toxicology study reports, or portions thereof, as appropriate.
• Partners with Business Development, Project Management, and Proposals to ensure successful client engagement, proposal development, study execution, and deliverables upon study completion.
• Participates in proposal generation and performs scientific/technical review of proposals.
• Drafts protocols, amendments, departmental notifications, and study comments forms, ensuring correct grammar, punctuation, consistency in format and style, and adherence to regulatory requirements and contract language.
• Identifies and incorporates exceptions to GLP conduct into GLP study protocols as applicable (e.g., systems/processes that are not validated).
• Reviews and approves Provantis study setups.
• Participates in all required training.
• Follows GLP and other appropriate regulatory (e.g., OECD, ICH) requirements to ensure all experimental data, including observations of unanticipated findings, are accurately recorded and verified.
• Observes appropriate safety and study requirements by reading, understanding, and following SOP's, GLP regulations, and study protocols.
• Reviews SOP's associated with study conduct and incorporates language into the protocol describing procedures or processes when necessary.
• Authors, updates, and/or reviews area-specific SOP's, ensuring that SOP's reflect current practices.
• Manages studies within time and budget constraints.
• Within defined policies and procedures, provides resolution to complex scientific problems within a specified program.
• May serve as Principal or Co-Principal Investigator or other key scientific position on government contract(s).
• Performs other duties as required.

Key Qualifications

• PhD degree in life sciences discipline with 5+ years prior experience; or Master’s degree with 8+ years prior experience or Bachelor's degree with 10+ years prior experience.
• Knowledge and ability to use the fundamental concepts, practices, and procedures of the particular field of specialization.
• Expertise in design, execution, interpretation of pharmaco toxicology studies.
• Effective verbal and written communication skills including correct grammar, spelling, and punctuation.
• Has advanced the field of knowledge in his/her specialty. Work directly impacts the present or future of the organization in significant ways
• Demonstrated competency in regulated environment including prior experience working in a GLP or similarly regulated environment.
• Requires ability to obtain and maintain US government security clearance.
• Must be willing to participate in random drug screening.

Preferred Qualifications

• Diplomate of the American Board of Toxicology certified OR DABT eligible - if not already certified, candidate will be required to become board certified within one year of hire date.

SALARY
Salary: $50/hr - $72/hr

This information reflects the anticipated base salary range for this position based on current national data. Minimums and maximums may vary based on location. Individual pay is based on skills, experience and other relevant factors.