Technical Project Manager CMC
vor 1 Woche
Your responsibilities
Responsibility and accountability for the chemistry, manufacturing, and controls (CMC) development of a gene therapy medicinal product (GTMP). Design and execution of the CMC development plan in coordination with the Wyss Zurich Translational Center. Identification and selection of suppliers of goods and services. Maintenance of communication with the suppliers. Preparation of regulatory documents related to CMC. Assurance of the regulatory compliance applicable to GTMPs in Switzerland, the European Union, and the United States. Serve as the primary point of contact for the GTMP production team. Reports regularly to internal and external stakeholders.Your profile
Advanced degree in pharmaceutical sciences or equivalent with a proven track-record of project management and cell and gene therapy product development. Minimum of 5 years of experience in pharmaceutical development (experience in process development or GMP manufacturing of cell and gene therapy products is highly advantageous. Knowledge of industry best practices and trends in ATMPs. A sound understanding of GMP regulations and guidance relevant to cell and gene therapy manufacturing. Experience in the early phase of the drug product life cycle is highly advantageous. Fluent verbal and written communication in English. Good communication skills in German are an advantage.What we offer
An active contribution to the development of a portfolio of gene therapies in collaboration with the Regenerative Medicine Technologies Platform of Wyss Zurich and the R&D team of the Institute for Regenerative Medicine of the University of Zurich. A diverse and motivated team awaits you with the aim of bringing the lead candidate into a phase I/II clinical trial. The conditions of the contract and the salary are subject to the regulations at the University of Zurich, cantonal regulations and your qualifications.-
Technical Project Manager Cmc
vor 1 Woche
Zürich, Zürich, Schweiz Wyss Zurich Translational Center VollzeitWyss Zurich Translational Center_Technical Project Manager CMC & ATMP - Pharmaceutical Environment60-100 % :The Wyss Zurich Translational Center is a joint accelerator of the ETH Zurich and the University of Zurich, which was made possible by a generous donation from a Swiss entrepreneur and philanthropist Dr. hc. mult. Hansjörg Wyss. The mission of Wyss...
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Technical Project Manager CMC
vor 1 Monat
Zürich, Zürich, Schweiz Universität Zürich VollzeitWyss Zurich Translational CenterTechnical Project Manager CMC & ATMP - Pharmaceutical Environment60-100 % The Wyss Zurich Translational Center is a joint accelerator of the ETH Zurich and the University of Zurich, which was made possible by a generous donation from a Swiss entrepreneur and philanthropist Dr. hc. mult. Hansjörg Wyss. The mission of Wyss...
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Technical Project Manager CMC
vor 1 Woche
Zürich, Zürich, Schweiz Universität Zürich VollzeitWyss Zurich Translational CenterTechnical Project Manager CMC & ATMP - Pharmaceutical Environment60-100 % The Wyss Zurich Translational Center is a joint accelerator of the ETH Zurich and the University of Zurich, which was made possible by a generous donation from a Swiss entrepreneur and philanthropist Dr. hc. mult. Hansjörg Wyss. The mission of Wyss...
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Technical Project Manager CMC
vor 1 Woche
Zürich, Zürich, Schweiz Universität Zürich VollzeitYour 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...
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