Director, DP MSAT

The role

The Director, DP MSAT will lead the Manufacturing Sciences and Technology strategy for biological drug products. This person will serve as the senior technical authority for contract drug product and fill-finish manufacturing, managing external partners and technical direction.

What you will do

• Serve as senior subject matter expert for DP/fill-finish manufacturing processes and technologies
• Direct technology transfer of drug product manufacturing processes to external manufacturing facilities
• Own final review and approval of CDMO cGMP batch documentation
• Drive process performance improvement in collaboration with internal and external teams
• Author and approve DP technical reports for cGMP activities and licensure
• Direct the development of sampling plans for cGMP batches
• Lead equipment selection, qualification, and start-up activities
• Provide senior oversight of CDMO investigations, root cause determination, and CAPA implementation
• Partner with DP development and procurement teams to define technical requirements
• Contribute to drafting regulatory filings and providing expert response to regulatory information requests

Required qualifications

• 15+ years of industry experience in DP development and manufacturing of monoclonal and/or bispecific antibodies
• Bachelor's degree in science or engineering discipline
• Command of scientific and technical principles underlying drug products and aseptic fill-finish operations for vial and prefilled syringe presentations
• Deep knowledge of GMP requirements, pharmaceutical manufacturing regulations, and validation and qualification principles
• Significant experience in pre-formulation and formulation methods supporting pre-clinical and clinical programs
• Experience leading technology transfer and scaling monoclonal antibody processes
• Proven experience managing and partnering with CMOs/CDMOs

Nice to have

• device and combination product experience
• experience with late stage development of biologics and licensure

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
• Scientific and technical mentorship

Before you apply

• Submit application through website and refer to Job ID 23407 in 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 endocrinology, women’s health, immunology, and oncology.