ESR 12: Translation of research grade (bench) manufacturing process into an automated GMP process for first-in-human clinical trials – Switzerland

Host institution: CUTISS AG (CUTISS), Switzerland


Supervisors:

  • Main supervisor: Dr. Vincent Ronfard (Chief Innovation Officer, CUTISS AG)
  • Co-supervisors: Dr. Laurent Barnes (Sr. R&D Manager, CUTISS AG) & Dr. Joaquin Urdinez (Team Leader R&D, CUTISS AG)

Enrolment PhD training program: UZH


Planned secondments:

Brief description:

Current treatment methodologies for patients with skin defects (e.g. burns) suffer from donor shortage and results in disfiguring debilitating scars. To increase the quality of life of these patients, we have developed denovoSkin™. Briefly, autologous single cells are isolated from small skin biopsy of a patient, amplified in culture, and used to bioengineer skin grafts, to finally be grafted on the same patient.

Because denovoSkin™ lacks pigmentation, as a next challenge, CUTISS AG aims to develop a robust platform for the isolation, characterization and in vitro expansion of patient-derived melanocytes that could either i) be included into a new generation of pigmented personalized bioengineered skin grafts,  ii) be transplanted to patients in areas that were previously treated with denovoSkin™, or iii) be transplanted to patients harbouring pre-existing non-pigmented skin patches caused by untreatable pigmentation disorders (e.g. vitiligo).

The candidate is tasked with the delivery of a robust melanocyte isolation, characterization, and expansion protocol. Additionally, he/she must assess melanocyte efficacy to pigment skin by in vitro, ex vivo and in vivo means. He/she will additionally work in the translation of these protocols into GMP-framed activities. The ESR is expected to closely collaborate with the company’s R&D and GMP teams, and potentially with external collaborators. He/she will ensure that the design and execution of the protocols comply with the requirements of ATMPs and Medical Devices production. The ESR will be responsible of conducting science to the highest ethical/scientific standards. Finally, he/she will be responsible of ordering and keeping track of the reagents/consumables needed for the project.


Project specific requirements:

Education Requirements:

  • MSc degree in a biological field (e.g. cell/molecular biology, tissue engineering, biotechnology or similar) or MSc degree in Bioengineering, Medical Devices
  • Note that this ESR position requires additional application for the Life Science Zurich Graduate School of UZH: https://www.lifescience-graduateschool.uzh.ch/en.html

Required Skills and Experience:

  • Experience with a wide range of in vitro cellular and biochemical assays
  • Aseptic cell culture           
  • Prior experience conducting research within a field of skin biology (e.g. pigmentation, melanoma, wound healing, stem cell skin biology) is highly advantageous

Desired Skills and Experience:

  • Hands-on experience with flow cytometry, immunohistochemistry or confocal microscopy
  • Basic understanding of biostatistics and basic experience with biostats software (Prism, MATLAB, or others)
  • Knowledge of QA/regulatory affairs (e.g. Good Manufacturing Practice)

Please apply before December 21, 2020 via this APPLY link.