プロフィール詳細

プロジェクトを作成

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Erin M.に依頼

United States

Drug Development Scientist with 10+ years of experience in CMC and MSAT roles │Expert in Cell & Gene Therapy

プロフィール概要

Experience in Vaccine Technology, Cell Therapy, Gene Therapy, Biologics, Medical Devices & Lyophilization Technology. Expertise leading Process Development, MSAT, CMC, Technology Transfers, CMO Management and Manufacturing efforts

専門分野

• ☆ Microbiology
• ☆ Virology
• ☆ Coronaviruses
• ☆ Zika Virus
• ☆ Retrovirology
• ☆ Adenoviruses
• ☆ Molecular Virology
• ☆ Microbiological Assays
• ☆ Biochemistry
• ☆ Immunoassay
• ☆ Apoptosis
• ☆ Binding Assays
• ☆ Cell Biology
• ☆ Cell-Based Assays
• ☆ Stem Cell Research
• ☆ Biotechnology & Bioengineering
• ☆ Biological Systems Engineering
• ☆ Microscopy
• ☆ Electron Microscopy
• ☆ Fluorescence Microscopy
• ☆ Data Analysis
• ☆ Data Collection
• ☆ Data Management
• ☆ Data Manipulation
• ☆ Cell Culture
• ☆ Primary Cells
• ☆ Cell Banking
• ☆ Cell Line Engineering
• ☆ Large Scale Cell Culture
• ☆ Cell Surface Receptors
• ☆ Industrial Biotechnology
• ☆ Cytometry
• ☆ Drug Development
• ☆ Drug Formulation
• ☆ Biologic & Biosimilar Development
• ☆ Biosafety Testing
• ☆ Microbiology Testing
• ☆ Bioanalytical Testing
• ☆ Drug Stability Testing
• ☆ Preclinical Research
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Vaccine Development
• ☆ Pharmaceutical Manufacturing
• ☆ Extractable & Leachable Testing
• ☆ Pharmaceutical Process Development
• ☆ Bioprocess Development
• ☆ Biologic & Biosimilar Manufacturing
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Manufacturing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Device Prototyping
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Hematology
• ☆ Leukemia & Lymphoma
• ☆ Infectious Disease
• ☆ Viral Diseases
• ☆ Ebola
• ☆ West Nile Virus
• ☆ COVID-19
• ☆ Eastern Equine Encephalitis Virus
• ☆ Clinical Laboratory Science
• ☆ Blood Banking & Transfusion Medicine
• ☆ Regulatory Affairs
• ☆ Immunotherapy
• ☆ Gene Therapy
• ☆ Pharmaceutical Technology

サービス

• Writing

Writing Medical Writing, Non-Medical Regulatory Writing, Technical Writing

職務経験

Manager, Drug Product Development & Manufacturing

n/a

1月 2025 - 現在

学歴

Masters in Microbiology and Biotechnology

Colorado State University - Global Campus - United States

8月 2014 - 5月 2015

Bachelor’s in Biological sciences

Colorado State University - Global Campus - United States

8月 2008 - 12月 2012

認定資格

• n/a

  n/a

  1月 2025 - 1月 2025