VP, Late-Stage & Commercial Biologics Development

The role

You will shape the CMC strategy of late-stage development programs through to commercialization. You will build and lead a late-stage Manufacturing Science and Technology (MSAT) function for antibody-based biologics.

What you will do

• Spearheading the overall late-stage process development strategy for upstream cell culture and downstream purification
• Overseeing process characterization and PPQ studies and establishing control strategies
• Championing the drafting and review of relevant CMC sections for global regulatory submissions
• Steering technical process transfers, process scale-ups, and manufacturing troubleshooting activities
• Developing, mentoring, and leading a high-performing team of scientists and engineers
• Navigating complex interactions with global health authorities regarding process validation and combination product regulations
• Supporting drug product process characterization and technical development of combination products
• Partnering with Quality Assurance, Regulatory Affairs, Supply Chain, Clinical and Commercial teams

Required qualifications

• Post-secondary degree in Chemical/Biochemical Engineering, Biotechnology, Biochemistry, or a related field
• 18-20+ years of related experience in biopharmaceutical Process Development, MSAT, or CMC
• Minimum of 8 years in a leadership role
• Heavy emphasis on mammalian cell culture and development of antibody therapeutics
• Proven track record in taking biologics from late-stage development through successful PPQ, BLA submission, and commercial approval
• Extensive experience managing tech transfers with CDMO partners and person-in-plant (PIP) oversight
• Ability to build, inspire, and manage high-performing technical teams in a fast-paced biotech environment
• Technical and regulatory understanding of combination products (pre-filled syringes, autoinjectors), including design controls and device integration

Benefits

• Equity
• Annual bonus dependent on team and company performance
• 6% (non-match) RRSP contribution
• CAD $1,500 annual Active Lifestyle Allowance
• Annual vacation
• Professional development opportunities
• Comprehensive health benefits

Before you apply

• Refer to Job ID 23400 in your cover letter
• Only selected candidates will be contacted for an interview

About the company

AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology.