Experience

Ardigen

• Poland
• Biotechnology Research
• 100 - 200 Employee

• Executive Vice President & Board Member at Ardigen SA

  • Oct 2022 - Present

  Cracow, Małopolskie, Poland

• General Director of the Immunology Business Unit

  • Oct 2020 - Present

  Cracow, Małopolskie, Poland



Mater Misericordiae University Hospital

• Ireland
• Hospitals and Health Care
• 700 & Above Employee

• Consultant Haematologist / NGS Laboratory Lead

  • Oct 2016 - Aug 2020

  Dublin, Ireland



Mater Private Hospital

• Hospitals and Health Care
• 200 - 300 Employee

• Consultant Haematologist

  • Oct 2016 - Mar 2020

  County Dublin, Ireland



Charité

• United States
• Civic and Social Organizations

• Production Quality Officer

  • Feb 2016 - Jul 2016

  Since 2016 I am a Production Quality Officer at Charité Stem Cell Facility where I: • develop, implement, and maintain the activities of flow cytometry based quality control processes for cellular products

• Pharmacovigilance Manager

  • 2011 - Jul 2016

  Since 2011 I am the Pharmacovigilance Officer at Charité Stem Cell Facility where I: • develop and implement pharmacovigilance processes • prepare SOPs and perform trainings for the personal • prepare Individual Case Safety Reports as well as Suspected Unexpected Serious Adverse Reactions and report them to the authorities • prepare and submit periodic safety update reports

• Development of clinical pathways

  • 2011 - Jul 2016

  In 2011 I developed a clinical algorithm for the extracorporeal photopheresis treatment of patients with acute and chronic GvHD. It consisted in: • Adaptating the process to the special on-side demands and current German regulations • Assignment of responsibilities to the involved personal at Charité Stem Cell Facility including: registration personal, doctors, nurses and laboratory staff • Providing explicit recommendations for treatment schedule and response… Show more In 2011 I developed a clinical algorithm for the extracorporeal photopheresis treatment of patients with acute and chronic GvHD. It consisted in: • Adaptating the process to the special on-side demands and current German regulations • Assignment of responsibilities to the involved personal at Charité Stem Cell Facility including: registration personal, doctors, nurses and laboratory staff • Providing explicit recommendations for treatment schedule and response evaluation • Developing standardized documentation charts and SOPs • Developing a quality control system and bio-banking procedures as well as a research data base • Performing staff-trainings including registration personal, nurses, doctors and laboratory personal In 2014 I supervised the development of a clinical algorithm for an autologous serum based eye-drops treatment of patients with ocular chronic GvHD. My job consisted in: • Defining the required product, product optimization and development of a manufacturing process conform to GMP-regulations • Supervising the development of standardized documentation and standard operating procedures • Co-Developing the phase II study protocol • Co-Developing commercialization and reimbursement strategies • Fundraising activities to guarantee the successful realization of the project (Max Rubner Preis) • Coordinating and supervising the project activities performed by doctors, nurses, manufacturing and quality control team

• Academic Teacher

  • 2009 - Jul 2016

  Berlin Teaching of medical students in internal medicine, hematology and oncology. Lectures and workshops on the treatment of GvHD.

• Consultant Haematologist; Medical Oncologist; Internal Medicine

  • Sep 2007 - Jul 2016

  Charité, Medical Department,Division of Hematology,Oncology and Tumor Immunology • Treatment of in- and outpatients with both solid and hematologic tumors. Responsible for the stem cell transplantation patients. Treatment of stem cell transplant patients that developed severe acute or chronic GvHD. • Diagnosis in hematology including cytology and flow cytometry. • Involvement in clinical trials in the treatment of hematological malignancies, particularly in cellular therapies.



Deutsche Forschungsgemeinschaft (DFG) - German Research Foundation

• Germany
• Research
• 200 - 300 Employee

• Post-Doctoral scientist and project coordinator

  • Jan 2010 - Jun 2016

  Transregional collaborative research centre TR36 - Berlin and Munich University Coordinator - Project for the development of a platform for the clinical application of TCR-engineered T cells with defined specificity Project 1: Application of HMMR-TCR-transduced T cells after haploidentical stem cell transplantation for patients with refractory AML Project 2: Application of MAGE-A1-TCR-transduced T cells for treatment of patients with refractory and high-risk multiple myeloma. Project 3: Multicenter phase I/IIa study using T-cell receptor gene therapy… Show more Coordinator - Project for the development of a platform for the clinical application of TCR-engineered T cells with defined specificity Project 1: Application of HMMR-TCR-transduced T cells after haploidentical stem cell transplantation for patients with refractory AML Project 2: Application of MAGE-A1-TCR-transduced T cells for treatment of patients with refractory and high-risk multiple myeloma. Project 3: Multicenter phase I/IIa study using T-cell receptor gene therapy in metastatic melanoma (Eudractnr.: 2011-002941-36) Coordination consists in: • Project scheduling • Coordinating activities of multiple teams - research, manufacturing, clinical, pathology • Contact with vendors • Developing a target product profile and a risk assessment manual • Co-developing a GMP-compliant manufacturing process (In cooperation with Prof.Dr. DJ. Schendel - EUFETS research lab) • Writing and editing of phase I protocols • Co-developing a flow-cytometry based immune monitoring (in cooperation with Prof. Dr. B. Sawitzki research group - Berlin- Brandenburg Center for Regenerative Therapies- and Beckman Coulter) • Preparing and documenting PEI advisory meetings (PEI = Paul Ehrlich Institute) • Calculating costs and coordinating fundraising activities • Managing and moderating team and consultant meetings • Presenting the project at internal meetings and international conferences Show less