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AbCellera Biologics1 week ago

Principal Scientist - Toxicology

On-site · Vancouver, British Columbia, Canada

Type
Full Time
Level
Senior Level
Education
Doctorate Or Professional Degree
Company size
Large

Job Summary

Lead planning, design, execution, and interpretation of nonclinical toxicology programs (GLP and non-GLP) in support of IND, CTA, and BLA submissions, including general toxicity and reproductive/to developmental toxicology, aligning with regulatory expectations and program strategy. Serve as primary scientific interface with CROs for protocol development, study conduct, data interpretation, and final reports to ensure timely, high-quality, GLP-compliant delivery. Represent the Nonclinical Safety function on cross-functional discovery and development teams to inform candidate selection, risk assessment, and program advancement. Provide critical scientific assessment of toxicology data and communicate risk-benefit evaluations to project teams and senior leadership, including implications for clinical development and regulatory strategy. Author and review nonclinical safety sections of regulatory documents (INDs, CTAs, IBs, BLAs) and contribute to global regulatory interactions. Drive development and evolution of integrated nonclinical safety strategies across the portfolio, maintain scientific leadership by staying current with advances in toxicology, and translate insights into internal best practices. Requirements include deep GLP/nonclinical toxicology expertise, hands-on experience with regulatory guidance (FDA, ICH, EMA), strong communication and leadership skills, and a PhD with substantial industry experience (8+ years preferred). The role is based in Vancouver, BC, Canada.

Required Qualifications

  • PhD in Toxicology or a related field
  • 8+ years of industry experience supporting biologics development
  • GLP-compliant nonclinical toxicology experience
  • Experience with US FDA 21 CFR Part 58
  • Strong scientific writing skills
  • Ability to lead cross-functional teams
  • Ability to communicate toxicology risk-benefit analyses to senior leadership
  • DABT accreditation (highly desirable)
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AbCellera Biologics

Principal Scientist - Toxicology

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