Miltenyi Biomedicine is a newly established international biopharmaceutical company that develops innovative cell and gene therapies. We are focused on bringing cancer treatments and regenerative therapies to patients. Our initial focus is on difficult to treat hematological cancers using CAR-T technology whilst exploring treatments for solid tumors. We are currently in discussion with the FDA, EMA and Japanese health authorities regarding initiating pivotal Phase II trials. We strongly believe that despite promising developments, there is significant room to improve on current cancer therapies.
Your roleYou are working in the newly founded department “Clinical Trial Execution Service” which is supporting our trial processes and activities with regards to our go-to-market strategy of Investigational Medicinal Products (IMP) - primarily in hematological and oncological indications. You are the expert and first point of contact for IMP related questions of the trial team and an important interface between our company and their internal groups, the manufacturer of the IMP as well as external partners (e.g. CRO).
- You plan, coordinate and perform IMP related trial processes and activities to assure efficient and compliant delivery of fresh and frozen IMP including documentation according to regulatory requirements. This includes that you oversee the life cycle of the IMP and comparator drugs from receipt to destruction including label design, packaging, IWRS (Interactive Response Technology) set-up, distribution and drug accountability.
- As the orchestration of the logistic processes is key for our CAR-T product flows for clinical trials, you support the implementation of the IMP related processes in our clinical trial execution platform in collaboration with the Clinical Supply Chain Department.
- In addition, you develop, supervise and optimize required manuals and working procedures including, but not restricted to IMP-Logistics Manual for Manufacturer, ordering of fresh/frozen IMP, IMP-thawing and administration at clinical trial site. You provide input to other IMP related documents, as required.
- You oversee and support the coordination of processes and follow-up in case of Out of Specification (OoS) Products during the clinical trials, document and escalate major IMP deviations and issues to appropriate stakeholders, and ensure timely corrective actions are completed and documented.
- Process improvement activities related to the IMP trial process are part of your responsibilities as well as supporting and/or performing qualification, training and supervision of the Manufacturer (CMO) providing the IMP. In collaboration with the Compliance Manager/QA department, you also coordinate regular compliance checks/audits at the CMO and ensure/provide internal and external team members IMP related training.
- You hold a scientific degree, e.g. in chemistry, biology, pharmacy, medicine and have several years’ experience in clinical research and management of clinical trials, ideally in the area of hemato-oncology and oncology, e.g. in the field of cell therapies.
- You have proven experience in at least one of the following, combinations preferable: life cycle management of IMPs (from receipt to destruction), GMP and/or GCP, project and process management.
- Previous experience in supervision, guidance or training to colleagues and setting goals is an asset.
- You have an exceptional understanding of processes combining big picture risk management with attention to detail.
- You are a highly motivated, open-minded team player with a proven ability to take initiative, prioritize and meet timelines in a very dynamic environment. You are a problem solver.
- You convince us with your thriving effective organization and communication skills (verbal and written in English, German is a plus).
- A modern workplace and exciting opportunities in the development of technologies with a secure future
- Cross-border intercultural cooperation and short communication channels
- 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, sport, and staff events
If you have the skills and qualifications for this position, please use the link to send us your details (application letter, curriculum vitae, references and certificates). Please give us some idea of when you can start and the kind of salary you are looking for.
