VP, Late-Stage & Commercial Biologics Development
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
18+ ans8+ gestionCandidates need a post-secondary degree in a biological or chemical field and 18 to 20+ years in biopharmaceutical process development or CMC, including at least 8 years in leadership. They need a record of taking biologics through PPQ and approval, plus experience with CDMO tech transfers and combination products.
Troubleshooting, Coaching, Process improvement, Quality assurance, Regulatory affairs, Supply chain management
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
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
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