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Amnon Eylath

Amnon Eylath

    BS
Senior Director Quality Assurance | Cambridge, Massachusetts    United States Of America
Clinical Pharmacology, Pharmacy & Medicine,...More
Pharmacy And Medicine, GMP,...More

Biography :

Dr. Amnon is Senior Director QA at Genzyme’s Allston Landing Facility in Boston. His prior work includes ARIAD Pharmaceuticals, Eli Lilly & Co, Amgen, ImmuLogic, Cellcor Therapies and Massachusetts General Hospital. Amnon has more than 25 years of R&D and biopharma experience, including the complete life cycle of biotech/small molecule drug development from discovery through process/method development, facility construction/validation, GCP quality, QA systems and operations, product commercialization, and post-launch disposition and compliance. Amnon is experienced in the due diligence, qualification and QA oversight of contract manufacturing and distribution organizations and contract labs across the US, Europe and Asia/Pacific.

Dr. Amnon collaborated closely with global SMEs from the FDA, EMA, biopharma companies, consultants and academia in developing the PDA Technical Report: TR No. 56: Application of Phase-Appropriate Quality Systems and GMP to the Development of Therapeutic Protein Drug Substance. He is co-author of PDA Technical Report 65: Technology Transfer. He has delivered training and seminars at PDA and ISPE venues as well as in the academic setting.

Dr. Amnon has a B.S. in biology from the University of Massachusetts and a Master’s degree in biology from Harvard – Extension.

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Specialties

Clinical Pharmacology, Pharmacy & Medicine, Research/Clinical Research

Interested Topics

Pharmacy and Medicine, GMP, GCP, Peptides, cancer therapy, GXP, GLP, Aseptic Processing, Decontamination, Sanitization, FDA, EMA, MHRA, Biology

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Languages

English

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