Pharmacokinetist Toxicologist

Battelle Memorial Institute

West Jefferson, OH

JOB DETAILS
HEADQUARTERS
West Jefferson, OH, US
LOCATION
West Jefferson, OH
POSTED
30+ days ago
Battelle delivers when others can’t. We conduct research and development, manage national laboratories, design and manufacture products and deliver critical services for our clients—whether they are a multi-national corporation, a small start-up or a government agency.


We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply.


We are currently seeking a Toxicologist (Chemist III - LifeSciences) .This position may be located remotely with 15% travel to Columbus or work-on-site in West Jefferson, OH .


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 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. 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.



MAJOR 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.

+ In collaboration with the business development team, 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 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.

+ May serve as Principal or Co-Principal Investigator or other key scientific position on government contract(s).

+ Performs other duties as required.


THE FOLLOWING IS REQUIRED



+ PhD degree in life sciences discipline with 1+ years prior experience or Master’s degree with 4+ years prior experience or Bachelor's degree with 8+ 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.

+ Must be a US citizen with the ability and willingess to obtain security clearance.

+ Ability to obtain/maintain certification in Chemical Personnel Reliability Program (NACLC required) and Biological Suitability Assessment Program.

+ Ability to obtain/maintain DoJ Security Risk Assessment (SRA) approval.

+ Ability to obtain/maintain CDC approval to work with BSAT material.

+ Must be willing to work in a biosafety level 2 (BSL2) and/or 3 (BSL3) (biocontainment) environment and able to wear appropriate respiratory protection.

+ Must be willing to be immunized with FDA licensed vaccines and Investigational New Drugs (IND) recommended for persons at risk to occupational exposure of biological agents.

+ Must be willing to participate in random drug screening.


THE FOLLOWING IS DESIRED



+ 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.


LEGAL DISCLAIMER



The above statements are intended to describe the nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, activities and skills required of staff members. No statement herein is intended to imply any authorities to commit Battelle unless special written permission is granted by Battelle's Legal Department.


BENEFITS


Battelle’s competitive benefits program includes comprehensive medical and dental care, matching 401K, paid time off, flexible spending accounts, disability coverage, and other benefits that help provide financial protection for you and your family.


_As a condition of employment, Battelle will inquire about COVID vaccination status, and in the event that vaccinations are mandated at a work location (including client site and Battelle sites) we expect all candidates to comply with these required safety protocols._


_Battelle is an affirmative action and equal opportunity employer. If a reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact_ _recruiting@battelle.org_ _._


_Battelle provides employment and opportunities for advancement, compensation, training, and growth according to individual merit, without regard to race, color, religion, sex (including pregnancy), national origin, sexual orientation, gender identity or expression, marital status, age, genetic information, disability, veteran-status, or any other characteristic protected under applicable Federal, state, or local law. Our goal is for each staff member to have the opportunity to grow to the limits of their abilities and to achieve personal and organizational objectives. We will support positive programs for equal treatment of all staff and full utilization of all qualified employees at all levels within Battelle._


For more information about our other openings, please visit www.battelle.org/careers

About the Company

Battelle Memorial Institute