Scientist II - Toxicology

Southern Research•Birmingham, AL

1h•Onsite

About The Position

The Scientist II functions as a subject matter expert within the Preclinical Operations Division and has oversight of the scientific elements of projects to ensure successful implementation and/or study completion of toxicology studies. This position will also serve as Study Director and 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. Individuals filling this position must be and remain knowledgeable of emerging trends and may contribute to and influence best practices within the discipline.

Requirements

Master’s degree with 10 years’ prior experience.
Expertise in design, execution, interpretation, and reporting of toxicology studies.
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 environments (e.g. GLPs, BMBL).
Previous experience serving as Study Director for general toxicology and other types of studies.
Ability to work in Biosafety Lab Level 2 and 3.
Accountable for some level of revenue generation.
Must be eligible to work in the United States without employer sponsorship.

Nice To Haves

Prior experience in developmental and reproductive toxicology would be a plus.
DABT certification is preferred but not required.

Responsibilities

Performs the role of Toxicology Scientific Subject Matter Expert (SME) on commercial or government contracts and grants.
Oversees capability builds, assay and model development, and validation of experiments conducted in Operations.
Partners with Business Development, Project Management, and Proposals to ensure successful client engagement, proposal development, study execution, and contract deliverables upon study completion.
Within defined policies and procedures, it provides resolution to complex scientific problems within a specified program.
Serve as Study Director for general toxicology and other types of studies.
Participates in all required GLP training.
Supports Project Manager and Business Development as Toxicology SME on assigned projects. Interfaces with client’s scientific staff as appropriate.
Contributes to study design.
Oversees and serves as a scientific and technical advisor for laboratory operations to execute model and assay development, validation experiments, and GLP toxicology studies.
Writes and assists in execution of validation plans.
Supports troubleshooting issues during the conduct of toxicology studies.
Monitors projects and programs, reviews toxicology data, and authors toxicology study reports, or portions thereof, as appropriate.
Participates in proposal generation and performs scientific/technical review of proposals.
Follows Good Laboratory Practices (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. Ensures compliance with all regulatory and safety requirements for work with biologic agents.
Observes appropriate safety and study requirements by reading, understanding, and following Standard Operating Procedures (SOPs), GLP regulations, and study protocols.
Accountable for some level of revenue generation.
Authors/revises SOPs, as appropriate.