Full-Time

Specialist

AbCellera Biologics

AbCellera Biologics

501-1,000 employees

Accelerates antibody drug discovery with data science

Data & Analytics
AI & Machine Learning
Biotechnology

$80,000 - $100,000

Equity, Annual Bonus

Mid, Senior

Vancouver, BC, Canada

Requirements
  • bachelor's or master's degree in a relevant scientific discipline
  • 5+ years of Quality industry experience within biotechnology, the pharmaceutical industry, or life sciences
  • 5+ years of quality system management experience in a GxP regulated environment
  • hands-on experience in Quality Risk Management as defined in ICHQ9
  • strong understanding and experience in the application of electronic quality management systems and continuous process improvement principles
  • experience in GMP manufacturing for biologics
  • thorough understanding of drug development processes from discovery through CMC development
  • strongly self-motivated
  • outstanding communicator and teammate
Responsibilities
  • Establishing, designing, implementing, maintaining, and monitoring QMS framework processes
  • Creating and maintaining QMS policies, standard operating procedures, and related documentation
  • Designing and leading AbCellera’s Quality Risk Management program
  • Continuously improving the QMS
  • Overseeing the performance and effectiveness of QMS programs
  • Supporting Health Authority inspections, partner audits, and supporting drafting of follow-up responses
  • Collaborating with training teams to provide insight and guidance on the planning and implementation of quality system training
  • Providing cross functional quality leadership and acting as a CMC/GMP compliance subject matter expert
  • Implementing department goals, utilizing critical thinking, and applying problem-solving techniques

AbCellera stands out as a leader in the biotech industry due to its unique approach to antibody drug discovery, combining expert teams, advanced technology, and data science to expedite the process from target to clinic across various therapeutic areas. The company's competitive edge lies in its ability to enable swift progress, cost reduction, and problem-solving in drug development for both innovative biotechs and leading pharmaceutical companies. Furthermore, AbCellera's commitment to technical innovation is evident in its recent presentation of new data on two T-Cell Engager Programs at SITC 2023, demonstrating its active role in advancing the field.

Company Stage

Series A

Total Funding

$393.1M

Headquarters

Vancouver, Canada

Founded

2012

Growth & Insights
Headcount

6 month growth

-3%

1 year growth

16%

2 year growth

77%