Technical Project Manager CMC & ATMP - Pharmaceutical Environment
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.
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.
Place of work
Start of employment
August 2024 or by agreement. Please submit your application documents (cover letter, CV, relevant certificates) in English or German.
Further information
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