Miltenyi Biomedicine GmbH | Business Coordinator
vor 7 Stunden
We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases. Our lead candidate, a tandem CAR T-cell product, is currently undergoing pivotal clinical trials on a global scale.
In the Clinical Trial Execution Service department you will support our study processes and activities in line with our go-to-market strategy for investigational medicinal products (IMPs), particularly in haematological and oncological indications. You will plan, coordinate and execute IMP-related trial processes and activities such as Chain of Identity (CoI) and Chain of Custody (CoC) management and requirements planning to ensure efficient and compliant supply of fresh and frozen IMP, including documentation in accordance with regulatory requirements. This includes monitoring the lifecycle of IMP and comparator products from receipt to destruction, including labelling design, packaging, IWRS (Interactive Response Technology) set-up, distribution and drug accountability.
As the orchestration of logistics processes is critical to the product flow of our CAR-T clinical trials, you will support the implementation of IMP-related processes in collaboration with the Clinical Supply Chain department.
Process improvement activities related to the IMP testing process will be part of your responsibilities as well as supporting the qualification, training and monitoring of the Contract Manufacturer (CMO) supplying the IMPs.
You have a degree in natural sciences, e.g. chemistry, biology, pharmacy, medicine and several years of experience in clinical research and clinical trial management, ideally in the field of haemato-oncology and oncology, e.g. in the field of cell therapies.
You will have proven experience in at least one of the following, preferably in combination Life cycle management of IMPs (from receipt to destruction, ideally with CAR-T cells or other ATMPs), documented experience with relevant legislation and international GMP, GDP and GCP guidelines, project and process management.
You will have an exceptional understanding of processes, combining big picture risk management with attention to detail.
A collegial corporate culture and flexible working hours enable time management on your own terms
Personalized employee development program: specialist and personal training courses provided by our own Miltenyi University
Diverse corporate benefits with regard to employee health, and staff events
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