Senior Scientist II, Occupational & Environmental Toxicologist

Role Summary

Senior Scientist II, Occupational & Environmental Toxicologist will perform risk assessments to support occupational, environmental, manufacturing, and regulatory filings. The role supports programs across AbbVie’s therapeutic areas and involves a broad range of modalities from early discovery through development to marketed products. The candidate will join Genetic, Environmental, and Occupational Toxicology (GEO Tox) within Development Sciences, Pre-clinical Safety, and provide technical leadership and mentorship to junior team members.

Responsibilities

• Critically evaluate literature and toxicology reports/summaries and utilize tools such as read-across and in silico data to generate toxicology product risk assessments. This includes toxicology support for extractables and leachables, health-based exposure limits (HBELs) including permitted daily exposure limits (PDEs) and occupational exposure limits (OELs), environmental risk assessments (ERA), and other contaminants.
• Successful collaboration with multi-functional teams to align on safety banding for implementation throughout the company.
• Engage in related external working groups to help drive industry standards and stay informed of upcoming regulations.
• Provide guidance and mentorship to junior team members in GEO Tox and adjacent departments.
• Plan and monitor studies at contract research organizations (CROs) for environmental assessments to support regulatory filings.
• Plan and monitor studies at contract research organizations (CROs) for worker safety studies to occupational safety and handling.
• Support evaluation/implementation of relevant new approach methodologies (NAM).
• Provide technical support for occupational health (hazard) categorizations and chemical registrations, including Globally Harmonized System of Classification and Labelling of Chemicals (GHS/CLP), and Safety Data Sheets (SDS).

Qualifications

• Required: Bachelor's Degree in toxicology or related discipline and typically 12 years of experience; OR Master’s Degree in toxicology or related discipline and typically 10 years of experience; OR PhD in toxicology or related discipline and typically 4 years of experience.
• Preferred: Previous experience in a pharmaceutical/biopharmaceutical or GMP/GLP industry setting providing risk assessments.
• Proven record of successfully evaluating safety risks.
• Excellent collaboration, multi-tasking, and communication skills.
• Excellent oral and written communication and attention to detail.
• Ability to work in a fast-paced environment and meet project deadlines.

Skills

• Preferred: Occupational Exposure Banding, performance-based exposure control limits, or evaluating toxicity data for Safety Data Sheets.
• Preferred: Risk assessment authoring.
• Preferred: In-depth knowledge and experience with regulatory guidance, e.g., ICH Q3C, ICH Q3D, ICH Q3E, ICH M7, ISO-10993-X.
• Preferred: Toxicity data mining in databases and literature.
• Preferred: Broad range of software proficiency and in silico predictive tools for toxicity, e.g., QSAR, OECD.
• Preferred: Board-certification (not required).