Kiadis Pharma is a biopharmaceutical company based in Amsterdam, The Netherlands. We focus on the treatment of blood cancers and inherited blood disorders aiming to make bone marrow transplantations, a risky procedure that is often the last hope for patients, safer and more efficient. This means we have a passionate team that is dedicated to make a huge difference for patients. If you are up to the challenge and would like to be part of our team, we are currently looking for a Senior Scientist Bioassay Development and QC.
As a Senior Scientist at Kiadis Pharma, you will:
- Lead the analytical development team to guide efforts for the optimization and validation of (cell-based) assays for release purposes.
- Stay up to date with EMA and FDA guidelines and assure compliance of analytical methods.
- Be involved in method transfers and validation strategies.
- Optimize method evaluations approaches using statistical tools such as DOE.
- Develop the control strategy.
- Lead batch comparability studies.
- Liaise with Quality Assurance on implementation of method improvements and implementation in GMP routines
The ideal candidate
- Holds a PhD in immunology, cell biology or equivalent.
- Has >3 years of experience in the biotech or pharmaceutical industry.
- Has experience with cell-based bioassay development and validation under GMP.
- Has experience in working with primary cells as well as immunological techniques.
- Has hands-on experience with statistical evaluation of assay performance and validation data using appropriate software, e.g. JMP, Minitab or equivalent, as well as method development using DOE.
- Has expertise in flow cytometry.
- Has experience in people
- Has demonstrated good leadership and communication skills, is used to working in a matrix organization and is quality-driven.
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)20 240 5250. You can e-mail your motivation letter and resume to firstname.lastname@example.org.
Kiadis Pharma’s allodepleted T-cell immunotherapy product candidate, given after a haploidentical hematopoietic stem cell transplantation (HSCT), is designed to reduce Graft versus Host Disease (GVHD). Single dose Phase 2 data with lead product candidate ATIR101 in patients with blood cancer shows a strong and clinically very relevant improvement over literature for the Baltimore protocol, with reduced risk of GVHD. Based on the positive results from the Phase 2 trial, the Company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in April 2017, for approval of ATIR101 across the EU as an adjunctive treatment in HSCT for malignant disease. Kiadis Pharma submitted responses to the Day 120 List of Questions in March 2018 and is on track to potentially obtain a positive CHMP opinion for ATIR101 in Q4 2018 and (conditional) approval from the European Commission in Q1 2019, which would allow for a European launch in H2 2019. Kiadis Pharma is conducting a Phase 3 trial with ATIR101 across Europe and North America (head to head against the Baltimore protocol). The first patient was enrolled in December 2017.
In September 2017 the US Food and Drug Administration (FDA) granted ATIR101 the Regenerative Medicine Advanced Therapy (RMAT) designation. ATIR101 has been granted Orphan Drug Designations both in the US and Europe.