Senior Scientist II, Occupational & Environmental Toxicologist

Role Summary

Senior Scientist II, Occupational & Environmental Toxicologist. The candidate will complete risk assessments supporting occupational, environmental, manufacturing, and regulatory filings. The position will support programs across AbbVie’s therapeutic areas and involve a broad range of modalities across all stages from early discovery throughout development to marketed products.

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 PDEs and OELs, and environmental risk assessments (ERA), and other contaminants.
• Collaborate with multi-functional teams to align on safety banding for implementation throughout the company.
• Engage in 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 and biocompatibility studies to support regulatory filings.
• Plan and monitor studies at contract research organizations (CROs) for worker safety studies to occupational safety.
• Support evaluation/implementation of relevant new approach methodologies (NAM).
• Provide technical support for occupational health (hazard) categorizations and chemical registrations, including GHS/CLP, and Safety Data Sheets (SDS).

Qualifications

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

Skills

• Occupational Exposure Banding, performance-based exposure control limits, or evaluating toxicity data for Safety Data Sheets.
• Risk assessment authoring.
• In-depth knowledge and experience with regulatory guidance (ISO-10993-X, ICH Q3C/D/E).
• Toxicity data mining in databases and literature (internal and external).
• Broad range of software proficiency and in silico predictive tools for toxicity.
• Board-certification preferred but not required.