Senior CMC Regulatory Affairs Manager
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
8+ YOECandidates need deep knowledge of CMC regulatory requirements, eCTD structure and Module 3 authoring for biologics and combination products. They also need a thorough understanding of Health Canada, FDA and EMA rules, a bachelor's or advanced degree in a science or engineering field, and about 8 years of relevant experience.
Regulatory affairs, Documentation, CTAS, Regulatory compliance
QC Analyst II
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
5+ YOECandidates need a Bachelor's degree with 5+ years of QC experience, or a Master's degree in a relevant science with 3+ years. They need strong GMP and data integrity knowledge, hands-on analytical skills, and experience with LIMS and chromatography data systems.
UPLC, CE-SDS, icIEF, ELISA, qPCR, UV-Vis
QA Specialist - Batch Record Review
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
5+ YOECandidates need a BSc in a relevant science with 5+ years of industry experience, or an MSc with 3+ years, in QA, QC or manufacturing in a cGMP-regulated environment. They need hands-on batch record review experience, knowledge of Health Canada, FDA, EU and ICH cGMP requirements, and strong attention to detail.
ERP system
QA Operations Specialist (15-month contract)
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
5+ YOECandidates need a BSc in a relevant science with 5+ years of industry experience, or an MSc with 3+ years, ideally in analytical sciences, quality control, or biologic drug manufacturing. They need a strong understanding of cGMP and Health Canada, FDA, EU and ICH requirements, plus a strong attention to detail and data integrity focus.
ERP system
Director, Combination Products & Device Development
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
15+ YOECandidates need a bachelor's or graduate degree in mechanical, biomedical or chemical engineering, at least 15 years of hands-on device engineering, and deep knowledge of FDA and ISO combination product standards. Management of technical teams and external partners is essential.
Leadership, Regulatory compliance, Coaching, Process improvement, Documentation, Risk management