Senior Clinical Supply Chain Coordinator

Vor 6 Tagen

Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine GmbH Vollzeit

Company Overview

Miltenyi Biomedicine is a pioneering biopharmaceutical company committed to advancing personalized cell and gene therapies. We are shaping the future of medicine by developing groundbreaking treatments for serious life-threatening diseases, ensuring their accessibility for clinical professionals and patients worldwide.

We focus on difficult-to-treat hematological cancers using CAR-T and other technologies, exploring treatments for various diseases. Our lead candidate, a tandem CAR T-cell product, is undergoing pivotal clinical trials globally.

Salary

The estimated annual salary for this position is around €80,000 - €110,000, depending on qualifications and experience.

Job Description

In our Clinical Trial Execution Service department, you will play a vital role in supporting study processes and activities aligned with our go-to-market strategy for investigational medicinal products (IMPs), particularly in haematological and oncological indications.

  • You will oversee the planning, coordination, and execution of IMP-related trial processes and activities such as Chain of Identity (CoI) and Chain of Custody (CoC) management, requirements planning, and documentation in accordance with regulatory requirements.
  • You will support the implementation of IMP-related processes in collaboration with the Clinical Supply Chain department, focusing on the orchestration of logistics processes critical to the product flow of our CAR-T clinical trials.
  • You will develop, maintain, and optimize necessary manuals and workflows for all relevant IMP processes, contributing to other IMP-related documents as required.
  • You will oversee and support the coordination of processes and tracking of out-of-specification (OoS) products during clinical trials, documenting and escalating major IMP deviations and issues to appropriate stakeholders.
  • Process improvement activities related to the IMP testing process will be part of your responsibilities, along with supporting the qualification, training, and monitoring of the Contract Manufacturer (CMO) supplying the IMPs.

Required Skills and Qualifications

To succeed in this role, you will require:

  • A degree in natural sciences, e.g., chemistry, biology, pharmacy, or medicine, with several years of experience in clinical research and clinical trial management, ideally in haemato-oncology and oncology.
  • Proven experience in at least one of the following areas: life cycle management of IMPs, documented experience with relevant legislation and international GMP, GDP, and GCP guidelines, project and process management.
  • Previous experience in supervising, mentoring, or training colleagues and setting objectives is an advantage.
  • An exceptional understanding of processes, combining big-picture risk management with attention to detail.
  • You are a problem solver, highly motivated, outgoing team player with a proven ability to take initiative, prioritize, and meet deadlines in a highly dynamic environment.

Benefits

We offer a modern workplace in Bergisch Gladbach with opportunities for mobile work, exciting prospects in technology development with a secure future, cross-border intercultural cooperation, short communication channels, a collegial corporate culture, flexible working hours, personalized employee development programs, and diverse corporate benefits regarding employee health and staff events.

Others

If you would like to work in an open, creative, and helpful team, we invite you to apply with your salary expectations and availability.

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