Posted 5 days ago
The Senior Clinical Scientist will drive early-phase oncology and endocrinology clinical development, translating preclinical findings into clinical strategies and designing and executing Phase 1–2 trials. Responsibilities include authoring protocols and regulatory submissions, monitoring safety and study data, coordinating cross-functional teams, and engaging with investigators and medical experts.
Posted 8 days ago
The Associate Director, Regulatory Affairs will implement global regulatory strategies and develop and oversee submissions for AbCellera’s biologics therapeutics portfolio. The role serves as the primary regulatory contact for project teams and authorities, providing guidance across the drug-development lifecycle and managing regulatory discussions, risks, consultants, and vendors.
Posted 8 days ago
The Senior Medical Writer prepares high-impact clinical and regulatory documents for the company’s clinical development programs, including submissions, briefing books, safety updates, and responses to regulatory agencies. The role also leads document reviews and content strategy, collaborates across project teams, keeps current with regulations, and helps adopt AI-assisted writing tools.
Posted 9 days ago
Le ou la gestionnaire principal(e), Affaires réglementaires CMC dirigera la stratégie, la rédaction et la coordination des dossiers réglementaires mondiaux pour des produits biologiques et combinés, de la phase préclinique à la commercialisation. Le rôle comprend la collaboration avec les équipes de Fabrication, Qualité, Développement analytique et d’autres équipes interfonctionnelles, ainsi que la gestion des risques réglementaires et la conformité des dossiers.
Posted 9 days ago
The Director, CMC Quality serves as the senior quality expert and representative for antibody products across clinical development through post-commercialization. Responsibilities include leading product quality strategy, managing risk and control strategies, ensuring regulatory compliance, assessing quality-impacting changes, and supporting regulatory submissions and health authority inspections.
Posted 10 days ago
L’analyste de systèmes cliniques soutient la mise en place et le maintien des systèmes d’essais cliniques, notamment par la formation des utilisateurs, le dépannage et les tests de validation. Le poste collabore avec les fournisseurs et les équipes cliniques, qualité numérique et TI pour gérer les changements, les mises en production et les améliorations des systèmes.
Posted 10 days ago
The Clinical Systems Analyst provides hands-on implementation and sustainment support for clinical trial systems, including user training, troubleshooting, validation testing, vendor coordination, and support for system changes and releases. The role works across Clinical Operations, Digital Quality, and IT to identify system issues and translate stakeholder needs into configuration improvements.
Posted 23 days ago
The Scientist II/Senior Scientist will develop and optimize separation-based analytical workflows to characterize proteins and support early-phase monoclonal antibody CMC programs. Responsibilities include generating and interpreting data, establishing laboratory best practices, evaluating technologies, supporting regulatory submissions, and mentoring junior scientists.
Posted 23 days ago
The QA for QC Specialist supports Quality Assurance Operations for biologics clinical manufacturing by reviewing and dispositioning QC laboratory data and maintaining quality and regulatory compliance. Responsibilities include supporting QC processes, reviewing analytical and manufacturing records, handling quality events and investigations, preparing regulatory submission data, and supporting inspection readiness and audits.
Posted 23 days ago
The QA Specialist reviews internal and external clinical manufacturing batch records and related documentation to ensure cGMP compliance, data integrity, and accurate batch disposition packages. The role also supports real-time manufacturing quality oversight, ERP material release, quality event investigations, risk assessment, inspection readiness, and continuous improvement.
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