QC analyst at Enlivex (Published: July 2020)

Enlivex Therapeutics, a dynamic, growing, clinical stage, cell-therapy Biotech Company located in Ness Ziona Science Park, is seeking a talented individual for the position of ’QC analyst’.

Reports To: QC manager

Summary

Performs all functions relating to Drug Product release assays; consistent with established Current Good Manufacturing Practices (cGMP), in conjunction with all relevant Standard Operating Procedures (SOP) to ensure quality requirements are within specifications.

Responsibilities

  • Execute Drug Product release assays according to approved SOPs in accordance with cGMP
  • Coordinate release assays sent to outsourced laboratories, record and report results
  • Validation of analytical methods
  • Support the optimization of existing methods
  • Maintain equipment in QC Labs
  • Environmental monitoring checkup
  • Write, review, and approve SOPs
  • Report and investigate deviations
  • Support Development activities
  • Comply with established quality, safety, and environmental procedures and policies
  • Report to QC Manager unusual product observations and analytical results while analyzing or handling samples.

Qualifications and Skills

  • B.Sc. in Life Sciences or Biotechnology, MSc. an advantage
  • Proven academic or industrial experience with Flow Cytometry (FACS)
  • At least 3 years of experience in QC at GMP level
  • Working with cells-lines, cell banking, experience in cell therapy - a major advantage
  • A dynamic team worker with ability to collaborate with other departments, capable of working flexible hours to support Clinical production
  • Well organized, reliable and task oriented, proactive, problem-solving and troubleshooting abilities

genertol@gmail.com