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.
- Ensure GMP compliance of Gamida Cell facilities to support global IND, CTA, BLA and MAA submissions, PAI inspections, and commercial manufacturing activities
- Prepare, review and approve master documents related to Manufacturing (including SOPs, test methods, validation protocols and reports)
- Contribute to investigations, risk assessments, change controls, deviations, and CAPAs
- Review and approve executed manufacturing and testing records for clinical production
- Support on site and virtual audit activities, to ensure ongoing compliance
- Conduct routine internal audits of the Manufacturing and support areas to verify compliance with cGMP
- Provide on-the-floor QA oversight during manufacturing activities, as needed
- Ensure that Manufacturing personnel work according to regulatory guidelines and relevant procedures
- Approve labels issued for clinical batches manufactured by Gamida Cell
- Prepare and approve CoAs for clinical batches manufactured by Gamida Cell
- Provide QA oversight clinical product shipment, as needed
Experience, Education and Specialized Knowledge and Skills
- Bachelor’s degree or higher in science-related field, or equivalent work experience
- Experience in a GMP Quality, Engineering or Manufacturing role (or combination thereof) within a commercial biopharmaceutical, cellular therapy, or gene therapy organization (Minimum of 2 years)
- Competent in the application of cGMP principles and change control
- Proficient in root cause analysis and risk assessment methodologies
- Knowledge of Quality Assurance requirements in the FDA and EMA regions is required
- Experience with Regulatory Inspections is preferred
- Excellent computer proficiency (MS Office – Word, Excel, Power Point and Outlook)
- Fluent English
To apply: Send resume and cover letter to firstname.lastname@example.org.