Scientist II, Product Quality & Occupational Toxicologist

BioSpace; North Chicago (IL); On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k)

Job summary

AbbVie in North Chicago, IL seeks an early career toxicologist to join GEO Tox in Development Sciences, Pre-clinical Safety. You will support occupational, environmental, and product regulatory risk assessments across therapeutic areas, including extractables/leachables and HBELs.

You will collaborate with multi-functional teams to classify hazards for company-wide implementation, and contribute to GHS/CLP and SDS processes for regulatory filings and product safety.

Qualifications

• Bachelor degree in toxicology, pharmacology, or related science with typically seven years of experience
• Understand relevant literature and apply framework to tasks
• Minimum of 3 years in pharma/biopharma GMP/GLP or regulatory setting
• Excellent collaboration and communication skills
• Excellent writing and attention to detail
• Ability to work in a fast-paced environment with multitasking

Responsibilities

• Critically evaluate literature and toxicology reports to generate risk assessments (HBELs PDEs OELs)
• Support product quality toxicology risk assessments for non-conformances and product complaints
• Experience supporting medical devices and combination products under ISO 10993
• Collaborate with cross-functional teams to align on safety classifications
• Support hazard categorizations and chemical registrations including GHS/CLP and SDS

Skills

toxicology

pharmacology

risk assessment

communication skills

writing skills

Education

Bachelor degree in toxicology

Master degree (5+ yrs)

Tools

Microsoft Office

Job description

Company Description

About AbbVie

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. 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 AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

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).

Qualifications

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.

AbbVie 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html