プロフィール詳細

プロジェクトを作成

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☆☆☆☆☆

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☆☆☆☆☆

Dr. Hanna B.に依頼

Israel

Biology, Biotech and Pharmaceutical Compliance , Regulatory affairs, Project Manager and sceintific writer

プロフィール概要

PhD biochemist with over 40 years of experience in the biotechnology and pharmaceutical industries. I excel at bridging the gap between research and implementation, having worked across the entire pharmaceutical development pipeline - from basic research to regulatory compliance. I'm particularly skilled in: Project portfolio management Regulatory compliance and validation Process development and optimization Technical evaluation of biotech innovations Sceintific writing

専門分野

• ★ Regulatory Writing
• ★ CMC Documentation
• ★ SOP & Protocol Writing
• ☆ Biochemistry
• ☆ Pharmacy
• ☆ Drug Development
• ☆ Pharmaceutical Manufacturing
• ☆ Pharmaceutical Process Development
• ☆ Bioprocess Development
• ☆ Clinical Trials
• ☆ Regulatory Affairs
• ☆ Pharmaceutical Technology
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Validation
• ☆ Product Compliance
• ☆ Technical & Scientific Writing
• ☆ Spec Sheets
• ☆ Literature Review
• ☆ Systematic Literature Review
• ☆ Copywriting
• ☆ Product Descriptions
• ☆ Scientific Proofreading & Editing
• ☆ Language Translation

サービス

• Writing

Writing Medical Writing, Technical Writing

職務経験

Evaluator

Ministry of Innovation, Science and Technology

- 現在

MTS Senior Director

Biotechnology general - Ferring

10月 2010 - 3月 2023

Projects management in Manufacturing

Biotechnology Generfal- Ferring

2月 2008 - 1月 2009

Kamada R&D VP and Process Development activities

Kamada

1月 2005 - 1月 2008

RA Manager

Omrix - Johonson &Johnson

7月 2004 - 8月 2005

Reseacher

Interpharm Ltd.

10月 1998 - 8月 2004

Process Development Project Manager

Insight

9月 1997 - 8月 1998

Scientific researchers

Biotechnology General

6月 1982 - 8月 1997

学歴

PhD

Hebrew University, Jerusalem

7月 1990 - 9月 1995

PhD (Virology)

Hebrew University of Jerusalem

1990 - 1995

MSc

Tel Aviv University

9月 1980 - 10月 1982

認定資格

• AI annotatioin

  I merit

  5月 2026 - 現在

• Certified Regulatory Compliance Manager

  Pharma Job

  2月 2002 - 現在

• Certified Pharmaceutical GMP Professional

  Biotechnology General

  10月 1998 - 現在

出版物

JOURNAL ARTICLE

Hanna Ben-Artzi, Yuval Ramot, Noam Kronfeld, Yakir Ophir, Nati Ezov, Sheli Friedman, Markku Saloheimo, Marika Vitikainen, Avi Avigdor, Ronen Tchelet, et al. (2022). Toxicity and Local Tolerance of a Novel Spike Protein RBD Vaccine Against SARS-CoV-2, Produced Using the C1 <i>Thermothelomyces Heterothallica</i> Protein Expression Platform . Toxicologic Pathology.

Hanna Ben-Artzi, Jenny Shemesh, Elisha Zeelon, Boaz Amit, Lawrence Kleiman, Marian Gorecki, Amos Panet (1996). Molecular Analysis of the Second Template Switch During Reverse Transcription of the HIV RNA Template . Biochemistry.

Hanna Ben Artzi, Jenny Shemesh, E. Zeelon, Boaz Amit, Lawrance Kleiman, Marian Gorecki, Amos Panet (1996). Ribonuclease H Activity during Initiation of Reverse Transcription Using tRNAlys/RNA Primer/Template of Human Immunodeficiency Virus . Archives of Biochemistry and Biophysics.

H. Ben-Artzi, E. Zeelon, B. Amit, A. Wortzel, M. Gorecki, A. Panet (1993). RNase H activity of reverse transcriptases on substrates derived from the 5' end of retroviral genome . Journal of Biological Chemistry.

Meir Fischer, Ruth Lifshitz, Tova Katz, Ilana Liefer, Hana Ben-Artzi, Marian Gorecki, Amos Panet, Elisha Zeelon (1992). Comparative analysis of native and cysteine-deficient HIV-1 reverse transcriptase . Protein Expression and Purification.

Hanna Ben-artzi (1992). ,.netToxicity and Local Tolerance of a Novel Spike Protein RBD Vaccine Against SARS-CoV-2, Produced Using the C1 Thermothelomyces Heterothallica Protein Expression Platform. Toxicologic Pathology. Volume 50, Issue 3.

Hana Ben-Artzi, Elisha Zeelon, Stuart F.J. Le-Grice, Marian Gorecki, Amos Panet (1992). Characterization of the double stranded RNA dependent RNase activity associated with recombinant reverse transcriptases . Nucleic Acids Research.

T Vogel, K H Weisgraber, M I Zeevi, H Ben-Artzi, A Z Levanon, S C Rall, T L Innerarity, D Y Hui, J M Taylor, D Kanner (1985). Human apolipoprotein E expression in Escherichia coli: structural and functional identity of the bacterially produced protein with plasma apolipoprotein E . Proceedings of the National Academy of Sciences.