Senior Associate, Quality Control, Raw Materials

Artiva Biotherapeutics

San Diego, California, United States
Base: $96,000 - $110,000; bonus/equity: not specif...
Gmp raw materials testing
Method development and validation
Sop authoring and review
This individual will support the Raw Materials program with development of new methods or procedures for raw materials testing, coordinating out-sourced testing and working with Sample Management for timely testing turnaround to meet critical material release for manufacturing Artiva’ products

Job Summary

  • This individual will support the Raw Materials program with development of new methods or procedures for raw materials testing, coordinating out-sourced testing and working with Sample Management for timely testing turnaround to meet critical material release for manufacturing Artiva’ products.
  • Perform and verse GMP testing of raw materials, including but not limited to identity, sterility, endotoxin, bioburden, mycoplasma, pH, osmolality, and compendial testing.
  • Support internal, external, and regulatory audits (FDA, EMA, etc.) and act as a subject matter expert (SME) for raw material testing methods and regulatory expectations.

Matching Summary

This individual will support the Raw Materials program with development of new methods or procedures for raw materials testing, coordinating out-sourced testing and working with Sample Management for timely testing turnaround to meet critical material release for manufacturing Artiva’ products.

Salary

Base: $96,000 - $110,000; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • GMP raw materials testing
  • method development and validation
  • SOP authoring and review
  • laboratory record maintenance
  • regulatory audit support

Nice-to-have

  • cell therapy-specific materials
  • cross-functional team collaboration
  • continuous improvement initiatives

Key Requirements

  • 4+ years cGMP QC experience
  • BS or BA in scientific field
  • raw material testing requirements knowledge
  • cell therapy-relevant materials experience
  • cGMP deviations, OOS, etc. experience

Work Rights

Not specified

Tailored Resume

Cover Letter