Director, DP MSAT

AbCellera · Vancouver

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Role summary

AbCellera seeks a Director of Drug Product Manufacturing Sciences and Technology to lead contract manufacturing strategy for biological drug products. The role requires serving as senior technical authority for fill-finish operations, technology transfers, and external partner oversight, with accountability for batch documentation, regulatory submissions, and process qualification.

What they're looking for

15+ years drug product development and manufacturing experience with monoclonal or bispecific antibodies
Bachelor's degree in science or engineering discipline
Expert knowledge of aseptic fill-finish operations for vials and prefilled syringes
Deep understanding of GMP requirements and pharmaceutical manufacturing regulations
Strong command of validation and qualification principles for biologics
Device or combination product experience preferred

What you'll be doing

Serve as senior subject matter expert and final technical authority for drug product and fill-finish manufacturing
Direct technology transfer execution from strategy through implementation at external manufacturing facilities
Review and approve CDMO batch documentation, protocols, and specifications to support cGMP production
Author technical reports on process characterization, validation, and qualification for regulatory submissions
Oversee CDMO investigations, root cause analysis, and corrective action implementation for manufacturing deviations

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