Technical Project Manager CMC

vor 1 Woche

Zürich, Zürich, Schweiz Universität Zürich Vollzeit

Your key responsibilities include:

  • Leading the chemistry, manufacturing, and controls (CMC) development of a gene therapy medicinal product (GTMP).
  • Creating and implementing the CMC development plan in partnership with the Wyss Zurich Translational Center.
  • Identifying and engaging with suppliers. Ensuring effective communication with them.
  • Preparing regulatory documents related to CMC.
  • Ensuring compliance with regulatory standards for GTMPs in Switzerland, the European Union, and the United States.
  • Being the main contact point for the GTMP production team.
  • Providing regular updates to both internal and external stakeholders.

Your qualifications:

  • Holding an advanced degree in pharmaceutical sciences or a related field, demonstrating a successful history in project management and cell and gene therapy product development.
  • Having at least 5 years of experience in pharmaceutical development (experience in process development or GMP manufacturing of cell and gene therapy products is advantageous).
  • Possessing knowledge of industry best practices and current trends in ATMPs. Thorough understanding of GMP regulations and guidance pertaining to cell and gene therapy manufacturing.
  • Experience in the initial stages of the drug product life cycle is beneficial.
  • Strong verbal and written English skills. Proficiency in German is a plus.

What you can expect:

Play a vital role in advancing a range of gene therapies through collaboration with the Regenerative Medicine Technologies Platform of Wyss Zurich and the R&D team of the Institute for Regenerative Medicine at the University of Zurich. Join a dynamic and motivated team working towards progressing the lead candidate into a phase I/II clinical trial. Compensation and conditions of employment adhere to University of Zurich and cantonal regulations, based on your qualifications.

Location:

Commencement:

Starting in August 2024 or as mutually agreed upon. To apply, kindly submit your application materials (cover letter, CV, relevant certificates) in English or German.

Additional information:

Reach out to Dr. Oleksandr Pastukhov for further details.

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