Principal Validation Engineer
Gmp
Posted on 1/30/2023
INACTIVE
AbCellera Biologics

501-1,000 employees

Accelerates antibody drug discovery with data science
Company Overview
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.
AI & Machine Learning
Data & Analytics
Biotechnology

Company Stage

Series A

Total Funding

$393.7M

Founded

2012

Headquarters

Vancouver, Canada

Growth & Insights
Headcount

6 month growth

-1%

1 year growth

16%

2 year growth

78%
Locations
Vancouver, BC, Canada
Experience Level
Entry
Junior
Mid
Senior
Expert
Requirements
  • 12-15 years of equivalent experience in validation and or engineering in a pharmaceutical and/or Biologics area
  • 4+ years managing complex validation/qualification projects
  • Experience with defending a validation program with Boards of Health
  • Independent problem solving and the ability to drive a team to support an ongoing cGMP Operation
  • Outstanding technical acumen, operational understanding, and GMP compliance in building and managing the new GMP facility
  • Detailed knowledge of ICH, FDA, EMA regulations for manufacturing of biologicals
  • Experience managing suppliers and 3rd party contract organizations
  • Experience managing an electronic validation system is preferred
  • The ability to apply pragmatic, risk-based decision making to the operation
  • Strong ability to be strategic, yet hands-on and detail oriented
  • Experience leading a site through Quality audits and/or regulatory inspections
  • Experience with CMC regulatory filings
  • A BS/MS/PhD in Biological Sciences or Engineering
Responsibilities
  • You are strongly self-motivated and are able to identify project needs and follow that up with building and implementing solutions
  • You are passionate about building dynamic new teams and capabilities that accomplish important goals
  • You have a bias towards innovation over industry standards
  • You are enthusiastic about applying your expertise in manufacturing operations
  • You are an outstanding communicator and teammate