Clinical Supply Coordinator - Cell Therapy

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Are you a challenge-seeker who is passionate about securing clinical trial supplies? Do you want to help us build and design a seamless and innovative clinical supply chain fit for cryopreserved drug products and novel therapies? Have you worked with phase 1 trials, and maybe advanced therapies before? Then we need you on board, to secure our growing stem cell based clinical trial portfolio. The positions We are growing and have 2 vacant positions available. You will join a small group of clinical supply specialists within the department focusing on planning the trial supplies for our upcoming stem cell therapy clinical trials. As we have only recently progressed to clinical trial phase, the positions have a potential for developing and you will be given the chance to take on a broad role, where you will manage or support both clinical supplies, drug development tasks and vendor management, based on your qualifications and the organisational needs. We need you to help us ensure that our stem cell-based products will successfully reach the clinical trial sites. That means that you will handle different steps of the clinical supply chain and develop processes and tools to ensure a robustness and steady execution:
  • Take accountability for processes to be in control and fit for cryopreserved stem-cell based products, devices and auxiliary materials such as wash, and reconstitution buffers needed for product administration.
  • Be part of the CMC core team and/or a clinical trial team as the responsible for translating their needs to realistic plans, and you will be expected to together with your colleagues take full end-to-end responsibility for the clinical supply chain.
  • Provide feasible and well described product handling documents and set up labels and orders and secure documentation from internal and external stakeholders.
  • Support to set up and design IWRS/RTSM, provide insights on trial product planning, labelling, and packaging aspects for advanced therapies, conduct trial protocol reviews with a sharp focus on clinical supplies and translate science to tangible procedures, where medication errors are minimized.
    • Qualifications Our ideal candidates would have an academic degree in Life Sciences (biology, biochemistry, pharmaceutical sciences, or other relevant discipline) at master level, preferably combined with 2-5 years relevant experience in clinical supplies, clinical trials or CMC development – preferably from planning to execution of phase 1 trials. You could also have a supply chain background, as we could benefit from that expertise in securing the many complex deliveries needed in multinational clinical trial logistics. Experience within the following is an advantage:
  • Experience in planning, set-up and execution of phase 1 clinical trials from a clinical supply angle.
  • Supply chain and forecasting experience.
  • Working with and selecting vendors/CMOs and working in CMC core team settings.
  • The willingness to learn about GMP/GCP regulatory framework of advanced therapeutic medicinal products (ATMPs) and to interpret these into best practises in our area.
  • Understanding of pharmaceutical drug development – such as oral or parenteral drug development or manufacturing of aseptic pharmaceuticals.
  • Problem solver abilities and strong communication skills, as well as the willingness to take risks and invent new paths.
  • Proficiency in English, both written and spoken.
    • As a person, you are open-minded and a good communicator by nature. You have a high level of energy that drives you and inspires your colleagues. You thrive in a changing and dynamic work environment, and in a job that requires you to investigate, take initiatives and think out of the box when challenges occur. You are a true team-player who enjoys working in close collaboration with colleagues in and out of the project teams. In exchange, we offer you a job, where variation is the norm and where your job tasks will be broad. More importantly, we have a high level of trust in you and your skillset, you will be given space to grow and make an impact and you will be supported by our fantastic colleagues who are just as passionate as we hope you to be. About the department The department Cell Therapy Process Technology and Clinical Supplies is part of Novo Nordisk’s newly established Cell Therapy R&D unit, where we develop novel cell replacement therapies for the treatment of serious chronic diseases, together with the rest of Novo Nordisk and with external collaborators. Our department focuses on the development of manufacturing processes and related analysis and setting up clinical supplies for our upcoming clinical trials. Diabetes mellitus type 1, Parkinson’s disease and chronic heart failure are only some of the indications we are currently working on. You will join an international and dedicated group of around 70 employees, including scientists, technical coordinators, laboratory technicians and student workers who are part of the CMC and Manufacturing business area in Cell Therapy R&D. We truly believe that cell therapies will make a difference in the lives of patients suffering from chronic diseases. If this awakens your interest, please apply, and support us in progressing our stem cell projects into the clinic. Working in Novo Nordisk At Novo Nordisk, your skills, dedication, and ambition help us change patient lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. Moreover, we recognise that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds, and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and the communities we operate in. Contact If you have any questions regarding the position, you may reach out to Tanja Villumsen, Clinical Supply Specialist +45 3079 3943 or Kristoffer Tømmeraas, Director + 45 3075 2648 Deadline 30th Jan 2023 Please note that applications will be reviewed continuously, and interviews will be planned as soon as a suitable candidate is identified; thus the advert may be closed prior to indicated deadline. We expect you to kindly provide a motivated cover letter, so we may understand your take on how you see yourself in the role. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


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    Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".

    Arbejdsstedet er beliggende i Måløv.

    Jobbet er oprettet på vores service den 9.1.2023, men kan have været deaktiveret og genaktiveret igen.

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