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+ ansCandidates 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
QA Specialist - Supplier Quality
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
5+ ansCandidates need a relevant science bachelor's degree and 5+ years of QA experience in a regulated life sciences setting (or a master's with 3+ years). They must know supplier quality management, global cGMP and regulatory requirements, and electronic QMS and ERP systems such as Veeva and SAP.
Veeva, SAP
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+ ansCandidates 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+ ansCandidates 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
External QA Specialist/Manager
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
5+ ansCandidates need a relevant science bachelor's degree and 5+ years of QA experience (Specialist) or 8+ years (Manager) in a regulated life sciences environment, including external biologics manufacturing. They need deep knowledge of global cGMPs, strong eQMS and SAP or Veeva skills, and excellent attention to detail and communication.
Veeva, SAP
Director, DP MSAT
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
15+ ansCandidates need 15+ years in drug product development and manufacturing of monoclonal or bispecific antibodies, plus a science or engineering bachelor's degree. They need deep knowledge of GMP, aseptic fill-finish for vials and prefilled syringes, and proven CDMO management experience.
Documentation, Procurement, Manufacturing processes, DP, Define technical requirements, Presentation skills
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+ ansCandidates 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