Scientist II, Product Quality & Occupational Toxicologist

About This Role

This role supports patient, environmental, and employee safety by conducting risk assessments for occupational, environmental, manufacturing, and product regulatory filings. The position involves working across AbbVie

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

Nice to have:

• 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

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees
• Eligible to participate in short-term incentive programs

About the Company

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. The company strives to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience, and products and services in its Allergan Aesthetics portfolio.