December 2nd, 2020 – South San Francisco – Cellares Corporation, a biotechnology company focused on revolutionizing cell therapy manufacturing, announced the appointment of Einav Kraft as Vice President of Quality. In this role, Einav will be responsible for managing and growing a world-class quality organization within Cellares. Additionally, she will ensure that the organization runs in a cGMP-regulated environment to manufacture cell therapies and meets the requirements for ISO 13485 certification.
“Einav brings a wealth of expertise in quality and will help us grow and advance our cell therapy manufacturing capabilities in a cGMP environment” said Fabian Gerlinghaus, Chief Executive Officer and co-founder of Cellares.
Einav has over sixteen years of leadership experience in Quality and Compliance in the Pharmaceutical, Biotech, and Medical Devices industries which includes establishing, implementing, and ramping phase-appropriate quality systems from the ground up in pre-clinical, clinical, and GMP commercial environments. She also has a proven track record in developing and implementing a quality vision and culture across multiple organizations. To this point, she has successfully hosted multiple health authority inspections and Pre-Approval Inspections (FDA, EMA, Israeli MOH, Russian MOH), ISO 13485:2016 Certification for Medical Devices, and dozens of various other successful regulatory and client inspections.
Most recently, Einav served as Site Head of Quality for the Contract Development and Manufacturing Organization (CDMO) Miltenyi Biotec Inc., in San Jose, California. Previously, Einav was the Head of Quality Assurance at Taro Pharmaceuticals in Israel and led Compliance for Novartis’ San Carlos, California site. Einav earned a Bachelor of Science in Biotechnology and a Masters in Quality Engineering, both from the Technion, The Israel Institute of Technology.