Scientist II, Product Quality & Occupational Toxicologist

About the role

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

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.