Do you want to play a significant role in bringing stem cell derived cell therapies to the patients? Are you familiar with early CMC processes and have a good understanding of GMP environment? If yes, this is the job for you - a brand new position that you can help us to shape further!

The Position

Delivering cell therapies and advanced therapy investigational products (ATIMP) in a clinical trial setting is not only about the cell product, and to be able to ensure product delivery we need a new colleague to support us.

We will need you to be able to support us on all things non-ATIMP, and you will play a big role in ensuring product and documentation delivery.

As Drug Product Lead (Specialist) in Cell Therapy CMC you will be responsible for the coordination of activates across several disciplines and organisations to enable clinical trial and auxiliary material and support to reach the treatment sites on time. In addition, some activities are outsourced and would require you to follow up and facilitate adherence to plans or replanning as needed. You will work closely with the CMC project manager, clinical supply coordinators, process owners, the analytical coordinator, the formulation responsible, and external partners.

You will have a central role in the CMC teams for the projects you are supporting. Your role will increase in importance as we get closer to preparing and executing the trials. You will closely interact with one of our many CMOs around the world e.g. in Sweden, UK, Japan and/or USA. Finally, you will play an essential role in supporting the writing of the CMC part of the clinical trial application for our cell therapy projects to reach to the patients worldwide.

Qualifications

You must hold a scientific academic degree in Life Sciences, e.g. biology, biochemistry, pharmaceutical sciences or other relevant discipline. Master level or above, preferably combined with +5 years relevant experience or a PhD within a relevant area and preferably some years of relevant experience.

The ideal candidate has experience within the following:

• Working with or solid knowledge of Early Phase CMC development and being part of cross functional CMC project teams.
• Working knowledge of cGMP and experience in investigational medical product manufacture and documentation.
• Experience with outsourced manufacturing and product oversight would be an asset.

• Previous experience or relevant courses within project management will be an asset.
• 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 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 laboratory.

Furthermore, you see yourself as being a good collaborator with experience working cross functionally and building strong partnership with stakeholders at all levels.

In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

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 stem 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 cell therapy projects into the clinic.

Working in Novo Nordisk

At Novo Nordisk you can look forward to change. We encourage our employees to make the most of their talent. And we reward hard work and dedication with the opportunity for continuous learning 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

For further information, please contact Tanja Villumsen, Clinical Supplies Specialist + 45 30793943 or Kristoffer Tømmeraas, Director + 45 3075 2648.

Deadline

11 December 2022

Please note that applications will be reviewed continuously, and the advert may close before the indicated deadline.

You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. In addition, please avoid the use of photos in your CV. This makes for a better and more fair process.

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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