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 (nadunolimab), one of the the Company's patented antibodies, 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 has initially focused on two forms of cancer where there is a big need: non-small cell lung cancer and pancreatic cancer where three clinical trials are on-going, and two trials are about to start in other cancer forms. For details see www.clinicaltrials.gov. The CAN04 project is also in late stage CMC development.

The Company has also started development of a new antibody targeting IL1RAP, CAN10. The CAN10 antibody has been designed for treatment of autoimmune and inflammatory diseases focusing on systemic sclerosis and myocarditis. The CAN10 project will enter clinical stage in 2022.

In addition to these two projects, Cantargia is developing a pipeline based on the CANxx-platform.

Cantargia is listed on OMX Stockholm's main list (Mid Cap). The company is in an expansive phase and has today about 25 employees, in addition, many consultants and contract companies are used. Cantargia has its office in Ideon Gateway in Lund.

For further information about Cantargia, please visit the company's website, www.cantargia.com.

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TILLSATT - Clinical Supply Manager


Cantargia in Lund is looking for a Clinical Supply Manager!

Cantargia is looking for a Clinical Supply Manager to join the growing company. 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. You should have a strong background and experience from biotech/pharma and good understanding of drug development and CMC for biologics.

The Clinical Supply Manager will act as a key interface between the CMC and clinical teams. The responsibilities include to ensure that all clinical trials have timely and adequate supply for administration of IMP to patients. As the projects are developing, this will also include Phase III studies on a global level. More specifically, this role includes demand forecasting, determination of an appropriate presentation to the clinical site and subject, setting production schedules, manage inventory targets and safety stock levels, order management and proof of delivery, return or destruction and global distribution logistics including import and export management. You will provide oversight to CMOs for labelling and packaging, drug depot service, transportation logistics and IMP relabeling coordination. In addition, you will have close collaborations with internal stakeholders, such as Clinical Operations, Regulatory Affairs and Quality, as well as external contacts with CMOs, to be successful in this role.

We are looking for someone who takes initiatives and has strong communication skills. The role requires an organized, structured, and proactive approach as well as accuracy and flexibility. The position puts high demands on being able to act independently but also to collaborate effectively both internally and externally.

As the company is small, you must have a "can do" attitude and not be afraid to roll up your sleeves. The desire to learn new tasks and a positive view of change are also good characteristics, as Cantargia is in a strong growth phase where working methods and organization will change continuously to adapt to the business needs.

The position is located at the head office Ideon Gateway in Lund, and you will report to VP CMC.



Main purpose of the job

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
• Drug supply forecasting and inventory oversight
• Set-up and approval of labels and packing materials; manage clinical labeling including label design, translation, and production
• Define drug supply activities at CMO’s
• Manage shipping and distribution; manage clinical packaging/distribution including negotiating contracts with CMO, designing clinical supply plans, and developing the distribution instructions with clinical supply chain vendors
• Oversight of international distribution and logistics for clinical programs, including importing and exporting clinical supplies
• Develop Pharmacy manual for clinical studies
• Review departmental SOPs and ensure updates and compliance with industrial standards
• Participate in drug product team meetings
• Take part in CMC team meetings and relevant tasks related to CMC
• Represent CMC in clinical study teams



Experience and qualifications

• 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 from working with CMO’s
• Fluency in English in speaking and writing
• Computer skills (Microsoft Office)


Required skills and personal characteristics

• Takes initiative, acts with confidence, and works under own direction
• A Team player who builds wide and effective networks of contacts inside and outside the organisation
• Good communication skills and understanding of alliance management
• Develops job knowledge and expertise through continual professional development. Curious and probing personality; open to participate in cross-functional discussions.
• Structured and quality minded
• Adapts to changing circumstances and making positive use of the opportunities it presents


Other

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.



Opportunities with the role

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.

Cantargia has several exciting projects in progress. Cantargia aims to develop drugs that can become an important part of the future's cancer treatment as well as in autoimmune / inflammatory diseases. You will have the opportunity to work in a small entrepreneurial pharmaceutical company, in the forefront of immuno-oncology, with research that can make a big difference for patients with e.g., non-small cell lung cancer and pancreatic cancer.


Contact

For inquires and more information about the position, please contact:

Catharina Herbertsson or Eva Runnerström, Senior Recruitment consultants at PeakSearch.



E: catharina.herbertsson@peaksearch.se
M: +46 706 152 772

E: eva.runnerstrom@peaksearch.se
M: +46 701 725 379



Application

Apply for the position at www.peaksearch.se