Toxicologist II (Chemist)

Toxicologist (Chemical)

The Life Science Research Team is seeking a Toxicologist (Chemical) 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. The Toxicologist functions as a study director within the organization and 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 and/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 may also be responsible for the supervision, oversight, scheduling, training, and mentoring of individuals within Battelle's Life Science Research Center. Individuals filling this position must be and remain knowledgeable of emerging trends and may contribute to and influence best practices within the discipline. This position is responsible for the organization, management, and business performance of non-clinical toxicology studies. This position will be located in West Jefferson, OH. This position is contingent upon award of work.

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.

Key Qualifications

Masters degree in life sciences discipline or Bachelors degree with 2- 5+ 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.

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 five years of hire date.

Demonstrated competency in regulated environment including prior experience working in a GLP or similarly regulated environment.