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