Scientist II, Product Quality & Occupational 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 support risk assessments for occupational, environmental, manufacturing, and product 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 early career toxicologist 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 risk assessments including extractables and leachables, health-based exposure limits (HBELs) including permitted daily exposure limits (PDEs) and occupational exposure limits (OELs).
Support product quality toxicology risk assessments to support non-conformances and product complaints.
Experience supporting medical devices and combination products under ISO 10993.
Successful collaboration with multi-functional teams to align on safety and compound hazard classifications banding for implementation throughout the company.
Support occupational health (hazard) categorizations and chemical registrations, including Globally Harmonized System of Classification and Labelling of Chemicals GHS/CLP, and Safety Data Sheets (SDS).
Requirements:
Bachelor degree in toxicology, pharmacology, or related science with typically seven years of experience, or Master degree with 5 years of relevant experience
Understand relevant scientific literature and apply theoretical framework to execute tasks/projects in a timely manner
Minimum of 3 years experience in a pharmaceutical/biopharmaceutical, GMP/GLP, or other regulatory setting desired
Exceptional collaboration, multi-tasking, and communication skills
Excellent writing skills and attention to detail
Ability to work in a fast-paced environment, comfortable with multitasking to meet project deadlines
Desired skills:
Risk assessment authoring experience
Toxicity data mining in relevant databases, internal, and external literature for use in compound risk assessments, classification, and labelling.
Knowledge and/or experience with regulatory guidance, i.e., ISO, ICH, etc.
Proficiency in Microsoft Office and other computer software systems

Employment type
Full-time

Work arrangement
No