Dorit Harati
SENIOR CONSULTANT
Experienced in Quality Assurance, QMS, CMC, validations, comparability, aseptic and cGMP manufacturing, facility design, design, and management of cross-continent technology transfer of cell therapies.
About Dorit
Dorit jointed Dark Horse Consulting in 2022 as a Senior Consultant, bringing expertise and leadership in Quality Assurance, QMS, CMC, validations, comparability, aseptic and cGMP manufacturing, facility design, and also design and management of cross-continent technology transfer of cell therapies: all according to the EU and FDA regulation.
While at Gamida Cell, Dorit served as the VP of Quality Assurance, Manufacturing and Logistics. During her service, two cell therapy products were transferred from research to early clinical phases and successfully completed international Phase 3 clinical trials with products manufactured in different manufacturing facilities abroad.
Dorit has extensive experience in building systems and departments from scratch and bringing them up to full operation capacity, including:
- building QMS;
- successful transfer of different technologies from R&D to inhouse GMP manufacturing and to different CMOs;
- comparability studies; establishing logistics systems to support the manufacturing of fresh and cryopreserved, time-sensitive personalized products at different multi-continent facilities to different transplant centers worldwide;
- writing different quality agreements; cGMP audits of CMOs for early and late phase manufacturing, suppliers, and other service providers;
- process and methods validation;
- design of clinical stage and commercial aseptic manufacturing facilities; and
- successful regulatory meetings with the FDA, EMA and different health authorities in Europe and Israel.
EXAMPLES OF RECENT WORK
- Co-design of commercial aseptic multi-rooms facility
- Managing the quality activities necessary for the design and built of the commercial facility
- Managing the safety and biological methods validation of a cell therapy product
- Designing the process and capacity validation of a cell therapy product
- Auditing the readiness of a CMO for commercial manufacturing
- Designing and managing a comparability study to show equivalent product quality when manufacturing is performed at Gamida Cell, the CMO used for Phase 3 manufacturing and the CMO planned to be used during commercial manufacturing
PAST EXPERIENCE
Gamida Cell Ltd.
VP, Quality Assurance, Manufacturing and Logistics
Perio Products Ltd.
Quality Control Laboratories Manager
Casali Institute of Applied Chemistry, The Hebrew University
Project Manager
EDUCATION
The Hebrew University in Jerusalem
B.S. in Chemistry