Katharina Kapoor
Medical and clinical Affairs at Schülke & Mayr- Claim this Profile
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English (IELTS 8.0) Professional working proficiency
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German Native or bilingual proficiency
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French Limited working proficiency
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Italian Elementary proficiency
Topline Score
Bio
Experience
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Schülke & Mayr
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Germany
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Medical and clinical Affairs
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Mar 2022 - Present
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SGS proderm
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Germany
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Research Services
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1 - 100 Employee
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Project Manager Clinical Research
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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
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MedPharm Ltd
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United Kingdom
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Study Director
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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
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Study Director
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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.
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Meddrop BioMedical Technologies GmbH
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Germany
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Medical Equipment Manufacturing
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1 - 100 Employee
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Project Manager Topical Formulation
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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)
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Almirall
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Spain
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Pharmaceutical Manufacturing
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700 & Above Employee
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Master Thesis
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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"
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Comvita Limited
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New Zealand
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Manufacturing
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100 - 200 Employee
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Research Intern
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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
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The University of Auckland
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New Zealand
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Higher Education
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700 & Above Employee
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Research Intern - pharmaceutical practical year
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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
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Apotheke Am Theater
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Germany
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Pharmaceutical Manufacturing
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Pharmacist in training - pharmaceutical practical year
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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
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Education
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Universitiy of Hamburg
Master of Cosmetic Science, Cosmetic Science -
The University of Auckland
IELTS certificate, English Language Academy (ELA) -
Pharmaceutical practical year
3rd state examina, Pharmaceutical Sciences -
Albert-Ludwigs-Universität Freiburg im Breisgau
Degree in pharmaceutical science, Pharmaceutical Sciences