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Doctoral Position in Minor Product Changes Waiver Chair of Pharmaceutical Technology and Biopharmacy, guideSkin third-party funded projectApplication deadline : 31.07.2026 At the Chair of Pharmaceutical Technology and Biopharmacy is available a Doctoral Position “Minor product changes waiver” (m/f/d) for the guideSkin third-party funded project for 36 months, starting on 1th November 2026. Host institution: Eberhard Karls University of Tübingen (EKUT), Pharmaceutical Technology and Biopharmacy, Germany Supervisor: Prof. Dominique Lunter Co-supervisors: Prof. Ali Tfayli, University Paris-Saclay (Academic); Dr. Yvonne Sichhart, Dermapharm AG (Industrial) Project description: Lifecycle management of cutaneous formulations frequently involves minor Q1/Q2 compositional changes that may not impact product performance. However, under the current EMA framework, even minor deviations often trigger full IVRT and IVPT reassessment, resulting in substantial experimental and regulatory burden. This project aims to establish a scientific and regulatory framework for waiving IVRT and IVPT studies following minor formulation changes. The work will systematically investigate the impact of controlled Q1/Q2 deviations on formulation microstructure (Q3) and performance. Formulations will be designed based on hypothesis-driven variations in excipient composition and characterised using microscopy and rheological profiling, followed by IVRT and IVPT. The project will intentionally include formulations exceeding current guideline limits to identify true performance-relevant thresholds. The outcomes will include identification of excipient classes and compositional ranges that do not affect performance, development of validated analytical workflows to detect meaningful differences, and establishment of a decision tree for regulatory justification of minor changes. The results will directly support WP1 objectives and contribute to regulatory simplification and cost reduction in lifecycle management. Host laboratory: The doctoral candidate will be hosted at the Institute of Pharmaceutical Sciences, Eberhard Karls University of Tübingen (EKUT), Germany. The institute is internationally recognised for its work in dermal drug delivery, IVRT and IVPT methodology and regulatory science. It provides advanced infrastructure for formulation development, rheological analysis and permeation testing. The research environment is interdisciplinary and closely connected to industrial partners, enabling translation of results into regulatory practice. The University of Tübingen is committed to equity and diversity and actively promotes equal opportunities. The University seeks to raise the number of women in research and therefore encourages qualified female academics to apply for the position. Disabled candidates will be given preference over other equally qualified applicants. Secondments: This project is carried out in collaboration with the following company partners, and extended mobility to their laboratories is expected during the project:
A willingness to travel and spend time abroad is therefore essential. Tentative starting date: 1st Nov 2026 Eligibility conditions:
Required skills:
Remuneration: Enquiries: How to apply Required documents:
A limited number of applicants will be invited for an interview and will be required to provide contact information of up to two contact persons for reference letters. Application deadline: The closing date for applications is 31st July 2026.
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