Full-Time

Quality Operations Manager

AbCellera Biologics

AbCellera Biologics

501-1,000 employees

Accelerates antibody drug discovery with data science

Data & Analytics
AI & Machine Learning
Biotechnology

$92,000 - $115,000

Equity, Annual Bonus

Senior

Vancouver, BC, Canada

Requirements
  • Bachelor's or Master's degree in a relevant discipline
  • 8+ years of GxP industry experience
  • Strong comprehension of current pharmaceutical regulations and guidances (FDA/Health Canada/EU/ICH)
  • Thorough understanding of biologically-derived Drug Substance manufacturing and testing processes
  • Strong experience with various software/databases such as ERP, MES, eQMS, and LIMS
  • Strong self-motivation and ability to identify project needs and implement solutions
Responsibilities
  • Providing quality oversight of Drug Substance (DS) manufacturing operations
  • Managing the Quality processes, procedures, systems, standards, and tools
  • Reviewing GMP documents and raw data for compliance
  • Reviewing and approving engineering processes
  • Managing Quality events such as deviations and investigations
  • Ensuring appropriate risk management of manufacturing operations
  • Maintaining collaboration with other Quality departments and AbCellera teams
  • Supporting the preparation, review, and/or responses to Regulatory Health Authority submissions

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%