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Hyunhee Oh PharmD, RPh

Hyunhee Oh PharmD, RPh

Undergraduate Research Assistant

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  • Timeline

  • About me

    Regulatory Affairs Development Manager at Samsung Bioepis

  • Education

    • Georgia Cumberland Academy

      2007 - 2011
      Academic High Honors Diploma

      Activities and Societies: Residence Assistance, Band Vice president, Class official, student Representative, National Honor society student officer.

    • Purdue University

      2015 - 2019
      Doctor of Pharmacy (Pharm.D.)

    • Purdue University

      2011 - 2015
      Bachelor’s Degree Major in Pharmaceutical Sciences, Minor in Biology

  • Experience

    • Purdue University

      Aug 2012 - May 2014
      Undergraduate Research Assistant

      • Conducted research regarding multifunctional protein, DJ-1 and studied how it triggers the onset of Parkinson disease• Performed PCR, digestion, and ligation to make clones of DJ-1 and to insert it into pET28B vector• Developed laboratory skills in protein purification process, such as bacterial inoculation, centrifugation, and chromatography• Performed gel electrophoresis, ethanol precipitation and mini preparation of plasmid DNA

    • Walmart

      Mar 2016 - May 2017
      Walmart Pharmacy Intern

    • Purdue University

      Jan 2017 - May 2018
      Graduate Research Assistant: Pharmacogenomic Study in Epilepsy and Autism

    • Kashiv Pharma LLC

      May 2018 - Jul 2018
      Business Development and Marketing Intern

    • Purdue University

      Jul 2018 - Aug 2019
      Graduate Student Researcher: Clopidogrel Risk Meta-Anlaysis

      Clopidogrel meta analysis

    • Eli Lilly and Company

      Jul 2018 - Jul 2018
      Global Brand Development Intern

      • Identified challenges in lupus clinical trials and formulated proper methodologies to design the study• Evaluated studies to apply findings in identifying a new indication candidate for an injectable product• Facilitated meetings across cross-functional departments to share findings and exchange feedback• Educated team members on an immune disease disorder to augment decisions of starting a trial

    • CVS Specialty

      Jan 2020 - Jul 2020
      IVIG Clinical Pharmacist

    • Samsung Bioepis

      Sept 2020 - now
      Regulatory Affaris Development Manager

      - Establish strategies for clinical and non-clinical issues of oncology and rare disease biosimilar products - Prepare non-clinical and clinical regulatory documents including but not limited to common technical document (CTD), regulatory response, briefing document, in collaboration with relevant groups/functions in RA, R&D, and clinical science divisions (medical team/clinical operation team)- Serve as a functional liaison between Research & Development/clinical science divisions and regulatory affairs team for non-clinical/clinical development of biosimilar product Show less

  • Licenses & Certifications

    • Purdue University Collaborative Leadership Certificate

      Purdue University
      May 2013