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GMP Manager

ETH Zürich
place
Zürich

1W

Online bewerbenopen_in_new

GMP Manager

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GMP Manager
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The Wyss Zurich is a joint accelerator of the ETH Zurich and the University of Zurich, which was made possible by a generous donation from the Swiss entrepreneur and philanthropist Dr. hc. mult. Hansjörg Wyss. The mission of Wyss Zurich is to drive the clinical translation and technology transfer of outstanding scientific discoveries into new therapies for patients and breakthrough innovations in the emerging fields of Regenerative Medicine and Robotics, and to promote hybrid technologies in these fields. Wyss Zurich brings together some of the world’s leading experts to form multidisciplinary teams, pooling their knowledge and expertise. For further information: wysszurich.uzh.ch.



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Project background
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Phire is developing a novel immunologic approach to selectively eliminate the patient’s healthy and diseased hematopoietic cells and therefore enable a hematopoietic stem cell transplant (HSCT) and potential cure. With this, we aim to be the catalyst that enables three times more HSCTs and thus the regeneration of a healthy blood system. The next step in this project will be the selection of and coordination with a Contract Manufacturing Organization (CMO) partner for the GMP production of our antibody.



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Job description
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Are you motivated to help us with the selection and coordination of a CMO partner? We are looking for an expert in Good Manufacturing Practice (GMP). In your role in our team, you will fulfill the following tasks:

  • Help us in the evaluation process of a CMO partner with:
    • Determining of principal selection criteria    
    • Comparing and standardizing offers           
    • Evaluating offers
    • Contract finalization         
  • Coordination and meetings with CMO partner          
  • Writing reports and protocols        
  • Tracking of timelines and budget   
  • Troubleshooting and risk management       
  • Controlling Requirements (formulation, vials, labels, etc.)      
  • Writing of the documentation associated with GMP production and Product Quality Attributes for the application at Swissmedic


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Your profile
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  • At least 3 years experience in a contract manufacturing organization (CMO) company
  • Degree in natural sciences, engineering, or medicine and additional professional training in quality and regulatory matters
  • Experience working with quality and risk management standards
  • Work experience in preparing documents for filing at National Competent Authorities
  • Good interpersonal skills, teamwork, multi-cultural compatibility
  • Fluency in German and English
  • Flexibility, motivated and self-driven attitude


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ETH Zurich
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\nETH Zurich is one of the world’s leading universities specialising in

science and technology. We are renowned for our excellent education,

cutting-edge fundamental research and direct transfer of new knowledge

into society. Over 30,000 people from more than 120 countries find our

university to be a place that promotes independent thinking and an

environment that inspires excellence. Located in the heart of Europe,

yet forging connections all over the world, we work together to

develop solutions for the global challenges of today and tomorrow.
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Interested?
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We look forward to receiving your online application with the following documents: 

  • CV
  • Motivation letter
  • Track record
  • Diplomas

Please note that we exclusively accept applications submitted through our online application portal. Applications via email or postal services will not be considered.

Further information about Phire is on our website. Questions regarding the position should be directed to Dr. Jonathan Kiefer, email jonathan.kiefer@wysszurich.ch (no application documents).



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