Director – QC Analytical/Bio-Analytical
Confirmed live in the last 24 hours
Vancouver, BC, Canada
Experience Level
  • Masters degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science field. A PhD is highly desirable
  • 12+ years of industry Quality Control experience within an FDA CBER/CDER or EMA regulated industry with expert working knowledge in at least one relevant QC department (e.g., Bioassay, Chemistry or Immunoassays technology)
  • 6+ years experience building, leading, developing, coaching, and mentoring a cross-functional team
  • Direct experience and knowledge in antibody CMC development, protein chemistry and/or molecular biology (Protein characterization and method development) is highly desirable
  • Excellent working knowledge of applicable industry regulations (FDA, EMA), guidance documents (e.g. ICH) and industry best-practices (e.g. PDA technical Reports)
  • Experience with implementation phase-appropriate QC management systems supporting CMC through IND/BLA in compliance with applicable regulations, guidelines, and industry best practices
  • Excellent analytical and problem-solving skills
AbCellera Biologics
Company Overview
AbCellera Biologics is a biotechnology company that develops antibody therapeutics to improve patient outcomes.