Technical Project Manager Cmc

Vor 6 Tagen

Zurich, Schweiz Wyss Zurich Translational Center Vollzeit

Wyss Zurich Translational Center_
**Technical Project Manager CMC & ATMP - Pharmaceutical Environment**
**60-100 % **: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 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.

Project Somagenetix is developing novel gene therapies for patients with primary immunodeficiencies. We are recruiting a Technical Project Manager with prior experience in cell and gene therapy manufacturing process development to join our team. At Somagenetix, you will have the leading role in establishing Good Manufacturing Practice (GMP) compliant production of genetically modified hematopoietic stem cell product for a phase I/II clinical trial.

**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.

**Place of work**: Moussonstrasse, Zürich, Switzerland

  • Project Manager Cmc

    vor 2 Wochen

    Zurich, Schweiz Hobson Prior Vollzeit

    Hobson Prior are working alongside a pharmaceutical establishment who are looking for a Project Manager CMC to join their team on a contract basis located in Zurich. For more information, please get in touch now! Please note that to be considered for this role you must have the right to work in this location. **Key Responsibilities**: - To initiate...

  • Associate Director, Global Regulatory Affairs Cmc

    Vor 6 Tagen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Associate Director, Global Regulatory Affairs CMC - Marketed Products in our Zurich office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an...

  • Associate Director, Global Regulatory Affairs Cmc

    vor 2 Wochen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as an **Associate Director, Global Regulatory Affairs CMC** based in Zurich. **Here, you will be a vital contributor to our inspiring, bold mission.** **OBJECTIVE**: - Responsible and accountable for regulatory CMC development,...

  • Gm Sci Commercial Cmc Submissions

    vor 2 Wochen

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    **About** the role**: **How you will contribute**: - **Maintain doc plan / timeline** - Receive TOC aligned with Reg-CMC strategy - Collaborate with Reg-CMC and Content owners to prioritize and align deliverables - ** Establish document structure** - Create vdoc and applicable templates - ** Support author management** - Provide support to meetings for...

  • Technical Project Manager

    Vor 6 Tagen

    Zurich, Schweiz WayRay AG Vollzeit

    WayRay is a Swiss-based tech startup with subsidiaries in Spain, US and China. We are on a mission to create a future where any transparent surface is a window into virtual worlds. Right now, we are seeking bright minds to join our team of talented professionals and bring our vision to life. At WayRay we like to work hard and play hard. We have strong roots...

  • Technical Project Manager

    vor 2 Wochen

    Zurich, Schweiz redhat Vollzeit

    **About the job**: - The Red Hat Consulting team is looking for a Technical Project Manager to join us in Zurich, Switzerland, Vienna, Austria, or remotely in one of these countries. In this role, you will manage services projects in the region of Austrian and Swiss Alps from initiation through to delivery and closure. You'll coordinate and conduct customer...

  • Technical Project Manager Balance of Plant

    Vor 6 Tagen

    Zurich, Schweiz Hitachi Zosen Inova Vollzeit

    **Technical Project Manager Balance of Plant**: Hitachi Zosen Inova AG Zürich (Schweiz) Presence / Mobile Work experience Manager First Level Engineer Project Management, Product Management **About us**: Hitachi Zosen Inova (HZI) is a global market leader in energy from waste (EfW) and renewable gas. HZI acts as an engineering, procurement and...

  • Technical Project Manager

    vor 2 Wochen

    Zurich, Schweiz JALET ASSOCIES Vollzeit

    This company is an innovative, dynamic and growing company with headquarters in Zurich, Switzerland, and representatives worldwide. It develops a product portfolio of FPGA-based electronic modules and FPGA-optimized IP solutions for industrial customers and research organizations. The company provides leading engineering services in FPGA system design, and...

  • GRA CMC Director

    vor 1 Woche

    CHE - Glattpark (Opfikon) - Zurich HQ, Schweiz Takeda Vollzeit CHF 200'000 - CHF 250'000 pro Jahr

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...

  • Technical Project Manager

    Vor 2 Tagen

    Zurich, Schweiz Hitachi Zosen Inova Vollzeit

    **Technical Project Manager - Water Steam Cycle**: Hitachi Zosen Inova AG Zürich (Schweiz), Hitachi Zosen Inova AG Presence / Mobile Work experience Technical occupations (other) **About us**: - Zurich-based green-tech company Hitachi Zosen Inova (HZI) is a global leader in solutions for energy transition and circular economy including Energy from...