Scientist II, Product Quality & Occupational Toxicologist

About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on Linked In,Facebook,Instagram,Xand You Tube .

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 Abb Vie’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

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

• The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.
  
  Individual compensation paid within this range will depend on many factors including geographic location,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• 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 toparticipatein our short-term incentive programs.

Note:

No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable.

Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent with applicable law.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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