Xintela is a biomedical company working in the field of regenerative medicine with first focus on treatment of osteoarthritis. For more information about the company, see www.xintela.se. We are currently expanding and building our own GMP facility at Medicon Village in Lund for manufacturing of stem cell based advanced therapy medicinal products (ATMPs) for clinical trials. The cleanroom is currently being finalized and the qualification/validation of the facility and equipment, as well as the creation of the quality system, is ongoing.
We have a strong committed team which we now need to expand with a GMP Manufacturing and Process Development Manager. In this position you will be responsible for the manufacturing of mesenchymal stem cells for clinical trials and work in tight collaboration with the different product development functions in the company including R&D, QA and QC. As a member of a dynamic team in a small company you will have the opportunity to participate in both early R&D and in preparations for clinical trials, and you will have a strong influence on the activities performed.
In this role you will be responsible for the management of the cleanroom as well as working hands on with product development and manufacturing. This includes participation in a variety of activities such as maintenance of cleanroom procedures and SOPs; qualification/validation of equipment, manufacturing processes and analytical methods; performance of laboratory experiments; handling of materials and reagents; manufacturing of batches and reporting of data.
• Managing the cleanroom and cleanroom procedures
• Development and Implementation of the manufacturing processes
• Planning of manufacturing activities and manufacturing timelines.
• Manufacturing mesenchymal stem cells for clinical trials
Preferred Experience and Qualifications:
• BSc or MSc, or similar, in relevant field.
• Experience in pharmaceutical development, preferably within ATMPs or biologics.
• Understanding of the translation from pre-clinical development to clinical phase.
• Experience of cell culture techniques.
• Knowledge of GMP/QMS/SOPs/QC.
• Experience in cleanroom/aseptic techniques.
• Experience in the preparation of documents for regulatory submissions (e.g. IMPD).
• Understanding of flow cytometry (FACS) analysis is advantageous.
• Business level written and spoken English.
• Strong interpersonal and networking skills.
• Strong computerized systems skills.
The person we are looking for should be problem solving, innovative, strategic minded and should thrive in a flexible work environment.
Send your application to Sara Baker (email@example.com) as soon as possible but no later than 2 May 2018. Applications will be reviewed continuously.
Xintela develops medical products for regenerative medicine and cancer based on its proprietary marker technology, XINMARK®. Xintela uses the technology to select and assure the quality of mesenchymal stem cells for the treatment of cartilage damage and osteoarthritis. In a study on horses, the company has shown that stem cells are safe to use and that they have a positive effect on the articular cartilage and the underlying bone after an injury. In addition, Xintela has developed an assay XACTTM for the quality control chondrocyte preprations in cell therapy of cartilage. XINMARK® is also used for the development of an antibody-based treatment (Antibody Drug Conjugate, ADC) against glioblastoma, the most common and aggressive form of brain tumors in adults. Positive preclinical results from cell studies and animal model have shown that the antibody has a killing effect on glioblastoma cells and thus has confirmed the concept. Xintela is listed on Nasdaq First North Stockholm since 22 March 2016. Xintela's Certified Adviser at Nasdaq First North is Erik Penser Bank AB, +46 8-463 80 00.
Below you will find the collected information on Xintela’s press releases, newsletters, diary events, films, media coverage and analyses.
Dr. Marcus Keep comments on Xintelas glioblastoma project.
Xintelas Chairman of the board and strategic advisor Greg Batcheller, tells us more about Xintelas potential and prospects.
Dr. Lisa Fortier at Cornell University, New York is interviewed by BioStock about Xintelas positive results in horse study.
In the following video interview, Karin explains her role at Xintela and what she considers to be Xintela’s primary strengths.
See the interview with Claes Post, member of the board in Xintela. The interview is in swedish with english subtitles.
See the interview with Sven Kili, member of the board in Xintela. The interview is in English (introduction is in Swedish).
See an interview with Xintela's CEO Evy Lundgren-Åkerlund, after the listing ceremony at Nasdaq First North.
Investor presentation from Lund - Jan 27
Interview with Xintelas CEO