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Arbetsbeskrivning
OVERVIEW OF THE VACANT POSITION
As Clinical supply manager, you will be part of a small multidisciplinary CMC team responsible for IMP supply to the clinical trials and early- as well as late-stage CMC development and validation. The Clinical Supply Manager will be responsible for implementing the clinical supply function at Cantargia and coordinating drug supply to clinical trials through CMO’s. Cantargia is looking for a candidate with a strong background and experience from biotech/pharma and good understanding of drug development and CMC for biologics.
PROFILE AND KEY RESPONSIBILITIES
Key responsibilities will include but not be limited to:
Manage and coordinate drug supply for providing IMP for clinical trials
Implementation of Clinical trial supply systems
Set-up and approval of labels and packing materials
Manage shipping and distribution
Drug supply forecasting and inventory oversight
Define drug supply activities at CMO’s
Pharmacy manual for clinical studies
Participate in drug product team meetings
Take part in CMC team meetings and relevant tasks related to CMC
Education and Experience
B.Sc or M.Sc in relevant discipline
Experience from the pharmaceutical/biotech industry
Experience in clinical drug supply, including setting up label text, handling of IMP, distribution with cold chain management
Trained in GDP and GMP
Experienced in setting up and working with clinical drug supply systems
Experience with working with CMO’s
Good communication skills in English
Personal Qualities
Structured and quality minded
A Team player
A curious and probing personality; open to participate in cross-functional discussions
Good communication skills and understanding of alliance management
This position offers an experienced clinical supply manager an opportunity to join a well-funded SME with a highly experienced and enthusiastic team. Being part of a small organisation offers the incumbent high visibility, broad responsibilities and an opportunity to make a real impact on how patients will be treated in the future.
THE COMPANY
Cantargia AB was founded in 2009/2010 based on a discovery made by Professor Thoas Fioretos and Dr Marcus Järås at Lund University. Their research showed that leukemic stem cells express a protein, IL1RAP, on the cell surface, which is not expressed to the same extent on normal stem cells. Cantargia's research has since then shown that IL1RAP is also expressed in a range of solid tumours.
IL1RAP is important for the cancer cells' ability to create a favourable environment for proliferation and expansion. Therefore, antibodies targeting IL1RAP could potentially be used to treat several different types of cancer, but also autoimmune and inflammatory diseases.
Cantargia specialises in antibody-based treatments. CAN04, the Company's patented antibody, has a dual mechanism of action. It fights cancer by activating the immune system and by blocking signals that lead to tumour growth. Treatment with CAN04 has the potential to become an important part of modern immuno-oncology therapies. Cantargia is focusing on two forms of cancer where there is a big need: non-small cell lung cancer and pancreatic cancer and has two on-going clinical trials and additional trials is in planning. For details see www.clinicaltrials.gov. The CAN04 project is also entering late stage CMC development.
The Company has also started development of a new antibody against IL1RAP, CAN10. The CAN10 antibody is being designed for treatment of autoimmune and inflammatory diseases focusing on systemic sclerosis and myocarditis. The CAN10 project has recently entered CMC development.
In addition to these two projects, Cantargia is developing a pipeline based on the CANxx-platform.
The Company was listed on Nasdaq Stockholm Main Market (Small Cap) in 2018 and is based in Lund, Sweden with less than 20 FTEs, excluding consultants and virtual structures and resources.
The position as Clinical Supply Manager will be based in Lund with some flexibility to work from home. A certain amount of international travel will also be involved.
For further information on Cantargia, please visit the Company website at www.cantargia.com.
Welcome with your application no later than 2020-01-15. We recommend sending your application today as interviews may take place on an ongoing basis.
Contact:
For more information or questions, please contact Peter Juul Madsen, VP CMC, Cantargia AB at peter.juul.madsen@cantargia.com or +46 (0)730 769 403.