Supports functional goals by integrating toxicology information and data, health-based safety information and regulatory requirements for manufacturing safety into well-reasoned and supportable safety assessments and recommendations for AbbVie products. Generates new safety assessments that anticipate and critically evaluate scientific or regulatory advances.
Core Job Responsibilities
- Classify drug candidates and chemical intermediates into Performance -based Level of Exposure Control (PBLEC) bands and develop Employee Exposure limits (EELs).
- Prepare Safety Data Sheets (SDSs) including classification of drug candidates, intermediates, and excipients pursuant to the Globally Harmonized System (GHS)
- Monitor vendor-contracted worker safety testing studies.
- Prepare product quality toxicology assessments to support non-conformances (e.g., extraneous matter assessments)
- Provide risk assessment support for extractables and leachables for combination products, medical devices, container closure systems and manufacturing components
- Prepare toxicology risk assessment to define permissible daily exposures (PDEs)/residual dose levels (RDLs) per EMA shared facilities guidance and RiskMaPP
- Conduct literature searches, maintain AbbVie's ToxInfo database, attend and participate in AbbVie's Drug Handling Committee (ADHC) meetings.
- Support other functions within the genetic, environmental and occupational toxicology organization such as providing toxicological evaluations for environmental toxicity and drug substance/drug product impurity risk assessments
- Position accountability/Scope
- The toxicology assessments and reports generated support health-hazard evaluations that can be used as a basis for decisions regarding product manufacture. The individual will maintain close communication with management and appropriate people across divisions
- MS degree with 2+ years of occupational toxicology experience, BS with 6+ years of occupational toxicology experience, or PhD with related experience.
- Must have industrial Occupational toxicology or product safety evaluation experience
- Proven ability to integrate safety data and develop health-based safety is preferred
- Experience interacting with and advising cross-functional teams
- Prior experience in preparing SDSs, establishing EELs, placing and evaluating toxicology studies is desirable
- Must be detail-oriented and experienced with computerized databases, knowing how to search for and locate scientific literature. Must be able to summarize data and prepare reports and work independently with minimal guidance. Must be able to work in a fast paced environment to meet critical timelines.