BioSpace
Senior Scientist II, Occupational & Environmental Toxicologist
BioSpace, North Chicago, Illinois, us, 60086
Overview
Senior Scientist II, Occupational & Environmental Toxicologist Genetic, Environmental, and Occupational Toxicology (GEO Tox) is a diverse team of scientists with the goals of supporting patient, environmental, and employee safety. 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. We are seeking an experienced toxicologist with a risk assessment background to join our team in Development Sciences, Pre-clinical Safety. 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. Collaborate 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, biocompatibility studies, and occupational safety studies to support regulatory filings. 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 with typically 12+ years of experience, OR Master’s Degree with 10+ years, OR PhD with 4 years of experience. Previous experience in a pharmaceutical/biopharmaceutical or GMP/GLP industry setting providing risk assessments is preferred. Proven track record of evaluating safety risks; excellent collaboration, multi-tasking, and communication skills. Excellent writing skills and attention to detail; ability to work in a fast-paced environment and meet project deadlines. Desired Skills
Occupational Exposure Banding, performance-based exposure controls, or evaluating toxicity data for Safety Data Sheets. Risk assessment authoring; regulatory guidance knowledge (ISO-10993-X, ICH Q3C, ICH Q3D, ICH Q3E). Toxicity data mining from databases and literature; familiarity with in silico toxicity tools. Broad software proficiency; board-certification preferred but not required. Additional Information
The compensation range described is the range of possible base pay, determined by geographic location and company discretion. This range may be modified in the future. Comprehensive benefits including paid time off, medical/dental/vision insurance, and 401(k) for eligible employees. This job is eligible to participate in short-term and long-term incentive programs. AbbVie is an equal opportunity employer. US & Puerto Rico only – for more information, visit the company’s Equal Employment Opportunity page. Reasonable accommodations are available upon request.
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Senior Scientist II, Occupational & Environmental Toxicologist Genetic, Environmental, and Occupational Toxicology (GEO Tox) is a diverse team of scientists with the goals of supporting patient, environmental, and employee safety. 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. We are seeking an experienced toxicologist with a risk assessment background to join our team in Development Sciences, Pre-clinical Safety. 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. Collaborate 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, biocompatibility studies, and occupational safety studies to support regulatory filings. 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 with typically 12+ years of experience, OR Master’s Degree with 10+ years, OR PhD with 4 years of experience. Previous experience in a pharmaceutical/biopharmaceutical or GMP/GLP industry setting providing risk assessments is preferred. Proven track record of evaluating safety risks; excellent collaboration, multi-tasking, and communication skills. Excellent writing skills and attention to detail; ability to work in a fast-paced environment and meet project deadlines. Desired Skills
Occupational Exposure Banding, performance-based exposure controls, or evaluating toxicity data for Safety Data Sheets. Risk assessment authoring; regulatory guidance knowledge (ISO-10993-X, ICH Q3C, ICH Q3D, ICH Q3E). Toxicity data mining from databases and literature; familiarity with in silico toxicity tools. Broad software proficiency; board-certification preferred but not required. Additional Information
The compensation range described is the range of possible base pay, determined by geographic location and company discretion. This range may be modified in the future. Comprehensive benefits including paid time off, medical/dental/vision insurance, and 401(k) for eligible employees. This job is eligible to participate in short-term and long-term incentive programs. AbbVie is an equal opportunity employer. US & Puerto Rico only – for more information, visit the company’s Equal Employment Opportunity page. Reasonable accommodations are available upon request.
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