QC Bioassay Associate

Quality Control Bioassay Associate

Office: Kiryat Gat, Israel  

• Company: Gamida Cell, Ltd.
• Posting Title: QC Bioassay Associate
• Department: Quality Control
• Function: Quality
• Reports to: QC-Bio Lab Manager

Gamida Cell is a leader in advanced cellular therapies and hematopoietic stem cell transplantation, with two FDA approved therapies, Omisirge® (omidubicel-onlv) and APHEXDA® (motixafortide). Omisirge® is a nicotinamide (NAM) modified allogeneic hematopoietic progenitor cell therapy that is potentially curative for patients with hematologic malignancies. APHEXDA® is a CXCR4 antagonist with long receptor occupancy indicated in combination with filgrastim to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma.

General Scope and Summary

The QC Bioassay Associate is responsible for performing analytical testing, supporting method transfers, and managing stability programs for late-stage clinical and commercial products. This role includes maintaining QC documentation, preparing Certificates of Analysis, ensuring equipment readiness, and supporting investigations and audits to maintain compliance. The position requires collaboration with cross-functional teams, strong problem-solving skills, and the ability to manage activities independently.

Roles and 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)
• Actively participate in the training/coaching of new employees in the QC lab
• 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.
• Almost independent working with different interfaces in the company, interacting with managers of other departments, meeting the deadlines of reports to these interfaces and closing the timelines for activity performance.
• Other tasks, as assigned by QC-Bio Lab Manager or QC Associate Director

Experience, Education and Specialized Knowledge and Skills

• 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
• Broad understanding of analytical method development, optimization, and validation – Preferred but not required
• Familiar with FDA, ICH, USP guidelines, cGMP regulations and laboratory safety procedures – Preferred but not required
• Excellent computer proficiency (MS Office – Word, Excel, Power Point and Outlook) – Preferred but not required