VP, Late-Stage & Commercial Biologics Development
AbCellera · Vancouver
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Role summary
AbCellera seeks an experienced VP to lead late-stage manufacturing science and technology strategy for antibody-based biologics, transitioning clinical programs toward commercial viability. The role involves managing process development, regulatory submissions, and CDMO partnerships while building and mentoring a technical team.
What they're looking for
- Post-secondary degree in Chemical/Biochemical Engineering, Biotechnology, Biochemistry, or related field
- 18-20+ years biopharmaceutical process development, MSAT, or CMC experience
- Minimum 8 years in leadership role managing mammalian cell culture and antibody therapeutics
- Proven success advancing biologics through PPQ, BLA submission, and commercial approval
- Extensive experience managing technology transfers with CDMO partners and person-in-plant oversight
- Technical and regulatory knowledge of combination products, design controls, and device integration
What you'll be doing
- Define late-stage process development strategy for upstream and downstream operations from Phase 2/3 to commercial readiness
- Oversee process characterization, PPQ studies, and establish control strategies aligned with QbD principles
- Draft and review CMC sections for global regulatory submissions including BLA, MAA, and IND amendments
- Manage technical transfers, scale-ups, and manufacturing troubleshooting across internal and CDMO sites
- Build and lead high-performing team of scientists and engineers while collaborating across functions
Privacy & handoff
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