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Location: Kiryat Gat, Israel | On-site
Gamida-Cell Inc., an Ayrmid Pharma Ltd. company, is amid a period of transformational growth with a focus on commercializing novel treatments for rare, specialty, and oncological diseases with high unmet need. In support of this evolution, Gamida-Cell is seeking to bring people into the company who have a passion for both helping patients and building corporate capabilities. Are you ready to assist us on that journey? Join us and be instrumental in our growth!
Gamida Cell is a leader in advanced cellular therapies and hematopoietic stem cell transplants, with two FDA approved therapies, Omisirge® (omidubicel-onlv) and APHEXDA® (motixafortide). Omisirge® is the first and only FDA approved cell therapy for allogeneic stem cell transplant. APHEXDA® is a stem cell mobilization agent indicated for autologous transplantation for patients with multiple myeloma.
Key Responsibilities
- Support analytical method technology transfer and for late stage clinical and commercial programs
- 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
- To lead a special area of responsibility for laboratory activity including planning of each part of activity, the division of roles within the laboratory (in collaboration with QC-Bio Lab Manager) and the placement of the activity in the work plan
Qualifications
- Bachelor’s degree or higher in science-related field, or equivalent work experience
- Hands on experience in a biopharmaceutical QC lab – Preferred but not required
- Preferred but not required:
- Broad understanding of analytical method development, optimization, and validation
- Familiar with FDA, ICH, USP guidelines, cGMP regulations and laboratory safety procedures
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Our privacy practices have been updated to reflect compliance with Amendment 13 to the Privacy Protection Law in Israel. View details in English or Hebrew
Gamida Cell has become aware that individuals have been contacted via social media offering employment within Gamida Cell.
We would like to inform you that this approach is not related to Gamida Cell. If you receive any suspicious requests, please do not respond. We strongly advise you not to share any personal information. Do not deposit any received cheques and do not remit money on any account. To be considered for a position of employment at Gamida-Cell, we require a complete interview process and in person communication with the hiring manager and one other permanent employee. At no point in the recruitment process do we solicit personal financial information or payment from applicants. Such requests should be considered fraudulent and reported to the police immediately.