Quality Control Associate Bioassay Lab

Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

Job Description

  • Execute testing per in-house analytical procedures and compendial guidance (USP, EP, JP)
  • Support stability programs for clinical and commercial products (including writing protocols/reports, assay execution, analyzing/trending data, investigating nonconformances)
  • Initiate and revise controlled documents related to the QC lab (including SOPs and test methods)
  • Ensure maintenance and operation of specialized QC equipment
  • Prepare Certificates of Analysis for clinical and commercial products
  • Support investigations associated with out of specification results; Implement corrective actions, as appropriate
  • Actively prepare for and participate in on-site and virtual audit activities, to ensure ongoing compliance

Experience, Education and Specialized Knowledge and Skills

  • Bachelor’s degree or higher in science-related field, or equivalent work experience
  • Hands on experience in cell culture and bioassays (FACS, CFU)
  • Familiar with FDA, ICH, USP guidelines, cGMP regulations and laboratory safety procedures – advantage
  • Excellent computer proficiency (MS Office – Word, Excel, PowerPoint, and Outlook) 

To apply: Send resume and cover letter to zivw@gamida-cell.com.

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