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
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.
- 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