Kiadis Pharma is focused on cell-based immunotherapy products, as an adjunctive to a haploidentical hematopoietic stem cell transplantation (HSCT), for the treatment of blood cancers and inherited blood disorders. The Company’s product candidates have the potential to make allogeneic HSCT safer and more effective for patients.
Based on the positive results from the single dose Phase II trial with lead product ATIR101™ in patients with blood cancer, the Company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in April 2017, for approval of ATIR101™ across the European Union as an adjunctive treatment in HSCT for malignant disease. In addition, Kiadis Pharma has received regulatory approval in various countries to start dosing patients in a Phase III trial with ATIR101™ that will be performed across Europe and North America. ATIR101™ has been granted Orphan Drug Designations both in the US and Europe.
The Company’s second product candidate, ATIR201™, will address beta thalassemia, an inherited blood disorder.
Kiadis Pharma was granted an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data by the EMA.
The Company’s shares are listed on Euronext Amsterdam and Euronext Brussels.
We are currently looking for an experienced Director QA Clinical Supplies who ensures that all QA & cGMP requirements are adhered to at our CMOs.
In this role, you will:
• Manage and resolve QA related non-conformances at CMOs and suppliers.
• Travel frequently to CMO facilities, both in Europe and in the United States.
• Provide support to external parties
• Ensure completeness and correctness of documentation.
• Steer the CMOs on a daily basis and audit suppliers on a regular basis.
• Advise and consult other departments on cGMP matters
• Function as a back-up for the department head
The ideal candidate
Holds a MSc in a (bio) chemical field. You have at least 8 years of experience in a similar role, preferably in a biotechnology company. To be successful, you’ll have to bring result-orientedness, integrity, tenacity, communication skills and networking skills. Furthermore, you are a team player who builds relationships to make sure we have excellent cooperation with our partners.
A challenging position in an innovative, fast growing, biotechnology company. Working in a fast-paced dynamic environment brings the opportunity to make your own mark within the organization.
You will be rewarded a competitive remuneration package, the opportunity for personal development and to contribute to make a huge difference for patients.
For further information, please contact Jeroen Elderhorst, HR Manager, by phone at +31 (0)20 3140 250. You can e-mail your motivation letter and resume to firstname.lastname@example.org.