Katharina Kapoor

Medical and clinical Affairs at Schülke & Mayr
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Contact Information
us****@****om
(386) 825-5501
Location
Hamburg, Hamburg, Germany, DE
Languages
  • English (IELTS 8.0) Professional working proficiency
  • German Native or bilingual proficiency
  • French Limited working proficiency
  • Italian Elementary proficiency

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Experience

    • Germany
    • Pharmaceutical Manufacturing
    • 300 - 400 Employee
    • Medical and clinical Affairs
      • Mar 2022 - Present

    • Germany
    • Research Services
    • 1 - 100 Employee
    • Project Manager Clinical Research
      • Jul 2019 - Jan 2022

      Conceptualization of clinical studies for - Medical devices, according to ISO 14155 - Medicinal products (proof of concept studies up to phase II studies, according to ICH GCP) Medical writing - Analysis of comprehensive study data - Study reports, lay summary, publications, marketing materials Conceptualization of clinical studies for - Medical devices, according to ISO 14155 - Medicinal products (proof of concept studies up to phase II studies, according to ICH GCP) Medical writing - Analysis of comprehensive study data - Study reports, lay summary, publications, marketing materials

    • United Kingdom
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Study Director
      • Mar 2018 - May 2019

      Development of topical and transdermal formulations; UK, US and IL-based sponsorsManaging pre-clinical studies for topical (liquid/semi-solid) and transdermal formulations including pre-formulation studies (“proof of concept studies”), formulation development studies and ex vivo performance testing (skin penetration & permeation)- Project takeover from business development and initiation with Sponsor, communication of timelines, study procurement- Conceptualising studies, composing and execution of study protocols- Analysing and compiling study data for regular sponosor updates, prepared sponsor presentations and study reports- Collaboration with the US department on performance testing studiesResponsible for study budgetManaged, monitored and reported study budget.- Forecast monthly revenue based on the progression of the studies- Reported study progress and milestone achievements to the finance department for invoicingManaged & delivered project expansionPro-actively presented project data/updates in teleconferences and client face-to-face meetings and made strategic recommendations for project progress leading to the expansion of the study.- Prepared proposal amendments for additional photo safety testing, performance testing, formulation development and stability testing- Collaboration with the business development team on contractual closureStudy execution Communication of study objectives, timelines and safety requirements to R&D teams.- Leading weekly project meetings and communicated Sponsor feedback to the teams- Preparing study protocol/plan amendments capturing additional experimental work- Organising logistics of study material, ensuring project transition from the UK to the US in a timely manner- Reporting to sourcing manager Show less

    • Study Director
      • 2018 - May 2019

      Professional with experience in the topical pharmaceutical field, specialising in topical/transdermal product design and product development such as creams, ointments, gels and transdermal patches.

    • Germany
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Project Manager Topical Formulation
      • Apr 2017 - Feb 2018

      - Formulation development of cosmetic microemulsions - Compile product information and prepare product information file (PID) - Communication with regulatory departments and external service providers (microbiology) - Formulation development of cosmetic microemulsions - Compile product information and prepare product information file (PID) - Communication with regulatory departments and external service providers (microbiology)

    • Spain
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Master Thesis
      • Mar 2016 - Sep 2016

      Master Thesis on topical film forming systems for pharmaceutical and cosmetic application: - Formulation development - Film characterisation (DSC, mDSC, confocal Raman microscopy, skin PAMPA assay) - Method development - Presentation on "Evalutation of Cosmetics" Master Thesis on topical film forming systems for pharmaceutical and cosmetic application: - Formulation development - Film characterisation (DSC, mDSC, confocal Raman microscopy, skin PAMPA assay) - Method development - Presentation on "Evalutation of Cosmetics"

    • New Zealand
    • Manufacturing
    • 100 - 200 Employee
    • Research Intern
      • Mar 2014 - Jun 2014

      Investigation of pro- and anti-inflammatory effects of methylglyoxal in Griess assay as well as performance of cell viability experiments (MTT assay) . Collaboration with the skincare research project manager: - Primos 3D skin assessment - volunteer recruitment Investigation of pro- and anti-inflammatory effects of methylglyoxal in Griess assay as well as performance of cell viability experiments (MTT assay) . Collaboration with the skincare research project manager: - Primos 3D skin assessment - volunteer recruitment

    • New Zealand
    • Higher Education
    • 700 & Above Employee
    • Research Intern - pharmaceutical practical year
      • Nov 2012 - May 2013

      During pharmaceutical practical year, I developed prototype liquid crystal/ICP systems (supervision by Dr. D. Svirskis). Using cross-polarized light microscopy coupled with hot stage and cryoSEM I revealed some of their inherent structures. While working on the project I mentored a summer student. Frequently presented research findings in small groups. Final research findings were presented at the School of Pharmacy Seminars. The project was proceeded by a PhD student. Supervision of 3rd semester students in the role of lab demonstrator. Show less

    • Germany
    • Pharmaceutical Manufacturing
    • Pharmacist in training - pharmaceutical practical year
      • Apr 2012 - Sep 2012

      Main responsibilities: - prescription formulation and compounding - quality testing - patient consultancy - medication management Main responsibilities: - prescription formulation and compounding - quality testing - patient consultancy - medication management

Education

  • Universitiy of Hamburg
    Master of Cosmetic Science, Cosmetic Science
    2014 - 2016
  • The University of Auckland
    IELTS certificate, English Language Academy (ELA)
    2013 - 2013
  • Pharmaceutical practical year
    3rd state examina, Pharmaceutical Sciences
    2012 - 2013
  • Albert-Ludwigs-Universität Freiburg im Breisgau
    Degree in pharmaceutical science, Pharmaceutical Sciences
    2006 - 2011

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