Senior Manager/Associate Director, QA Operations
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
12+ ans5+ gestionCandidates need 12 years of GxP experience, including at least 5 years in a Quality management or leadership role, plus a Bachelor's or Master's degree. They must know FDA, Health Canada, EU and ICH regulations, have biological Drug Substance and aseptic manufacturing experience, and be proficient in SAP, eQMS and LIMS.
SAP, eQMS, LIMS
Senior Engineer, 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,…
8+ ansCandidates need 8+ years of direct drug delivery or combination product experience, ideally with prefilled syringes or autoinjectors. They also need knowledge of FDA design controls, ISO standards, and working with external device partners.
prefilled syringe, autoinjector, needle safety systems
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