Toxicology Research Scientist
4 weeks ago
Battelle Memorial Institute is seeking an experienced Toxicologist to support our clients' toxicology and inhalation research programs at our West Jefferson, OH lab. Our multidisciplinary integrated approach to providing critical solutions for our pharmaceuticals, biotech, agrichemical, industrial, and government clients increases the speed of development while maintaining quality and compliance.
Key Responsibilities- Serves as Study Director on toxicology, biodistribution, pharmacokinetic, efficacy, and related studies for commercial and government sponsors.
- Interfaces directly with client's scientific staff as appropriate.
- Designs toxicology studies to develop animal models and then test medical counter-measure efficacy.
- 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.
- In collaboration with the business development team and senior toxicology staff, is responsible for new pipeline development; accountable for some level of revenue generation.
- 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 FDA 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.
- Oversees the building of new capabilities to bring in new technologies and services.
- Within defined policies and procedures, provides resolution to complex scientific problems within a specified program.
- PhD degree in life sciences discipline or Masters degree with 2- 5+ years prior experience or Bachelor's degree with 5- 8+ years prior experience.
- Expertise in in-vivo design, execution, interpretation of small-molecule toxicology studies.
- Effective verbal and written communication skills including correct grammar, spelling, and punctuation. Prior presentation experience.
- Ability to obtain and maintain a U.S. government security clearance (U.S. citizenship required).
- Additionally, will require ability to obtain and maintain the following: DOJ Security Risk Assessment approval, CDC Approval to work with BSAT material, Chemical Personal Reliability Program (NACLC required) and Biological Suitability Assessment Program. Ability to work in biosafety level 2 (BSL2) (biocontainment) and wear appropriate respiratory protection. Requires participation in random drug screening. Willing to be immunized with FDA licensed vaccines and Investigational New Drugs (IND) recommended for persons at risk to occupational exposure of biological agents.
- Diplomate of the American Board of Toxicology certified OR DABT eligible - if not already certified, candidate will be required to become board certified within five years of hire date.
- Demonstrated competency in regulated environment including prior experience working in a GLP or similarly regulated environment.
Battelle Memorial Institute offers comprehensive and competitive benefits to help you live your best life. Our benefits include:
- Balance life through a compressed work schedule: Most of our team follows a flexible, compressed work schedule that allows for every other Friday off, giving you a dedicated day to accomplish things in your personal life without using vacation time.
- Take time to recharge: You get paid time off to support work-life balance and keep motivated.
- Prioritize wellness: Stay healthy with medical, dental, and vision coverage with wellness incentives and benefits plus a variety of optional supplemental benefits.
- Better together: Coverage for partners, gender-affirming care and health support, and family formation support.
- Build your financial future: Build financial stability with an industry-leading 401(k) retirement savings plan. For most employees, we put in 5 percent whether you contribute or not, and match your contributions on top of that.
- Advance your education: Tuition assistance is available to pursue higher education.
- Flexible work arrangements: You have options for where you work and when you work.
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