Diplom Biologin Nicole Cillien

Mrs Nicole Cillien completed her studies in biology at the University of Göttingen. Previously she finished the education as a medical-technical laboratory assistant in Bückeburg and as a medical-technical radiology assistant at the University Hospital  in Tübingen. In 1988 she began her professional career as a medical-technical assistant in the tumour immunology cell laboratory at the Women’s University Hospital in Göttingen with Dr Thomas Neßelhut. Together they worked on autologous tumour vaccines for active specific immunotherapy.

In 1993, she joined Dr Thomas Neßelhut in his practice in Duderstadt to set up the GMP-laboratory for cellular therapies (Institute for Tumour Therapy, later the Joint Practice for cell therapy) and to obtain a manufacturing authorisation in accordance with §13(2b) of the  German Medicines Act. She supported the establishment of further laboratories for cell therapy laboratories in Aschaffenburg (Dendrimun GmbH), Cologne (IOZK) and Jakarta.

To date, she has worked in various pharmaceutical law functions in the GMP laboratory. As a control manager (according to §15AMG) in Duderstadt as well as at the company Dendrimun GmbH in Aschaffenburg and as Head of Quality Assurance at the joint practice for Cell Therapy Duderstadt.

Education & Experience

1996

Diploma in Biology, Georg-August-University Göttingen, Specialising in    microbiology and immunology. The diploma thesis was done in co-operation with the company Scharper & Brümmer GmbH in Salzgitter. The cell biology topic of the thesis investigated the influence of phytoestrogens on human carcinoma cells.

1988

Final examination as a medical-technical radiology assistant,  University Hospital Tübingen

1987

Final examination as a medical-technical laboratory assistant, Bernd-Blindow-School, Bückeburg

1993-1999

Laboratory Manager

Institute for Tumour Therapy, Dr Thomas Neßelhut

2000-2010

Quality Management Officer

Institute for Tumour Therapy, Dr Thomas Neßelhut, 37115 Duderstadt.

Development of a GMP-compliant QM and QA system for the application for a manufacturing authorisation according to §13 AMG

2000-2006

Quality Management Representative and Control Manager

(§15 para. 3 in conjunction with §19 para.2 AMG in the 11 AMG amendment valid at the time) Institute for Tumour Therapy, Dr Thomas Neßelhut, Duderstadt. Company with authorisation to manufacture medicinal products in accordance with §13 AMG for cell therapies

  • Fulfilment of the tasks of the head of quality control in accordance with                  § 12 of the AMWHV
  • Support of the Qualified Person in the fulfilment of the responsibility in accordance with the provisions of § 19 of the Medicinal Products Act.

2003-2005

Control Manager in Aschaffenburg

(according to §15 para.3 with §19 para.2 AMG in the valid AMG-amendment) Dendrimun GmbH, European Society for Dendritic Cell and SubstitutionTherapy, 63741 Aschaffenburg, company with authorisation to

manufacture of medicinal products according to §13 AMG for cell therapies

2006-2009

Quality Manager, deputy laboratory manager

Institute for Tumour Therapy, Dr Thomas Neßelhut, 37115 Duderstadt

Production of cell therapeutics as an exemption regulation according to former

  • 4a AMG ‘one-hand regulation’ for treating physicians without a licence according to §13 AMG

2010-2018

Head of Quality Assurance and Quality Control

Praxisgemeinschaft für Zelltherapie Duderstadt, GmbH & Co. KG, 

37115 Duderstadt (previously Institute for Tumour Therapy)

Since 2018

Head of Quality Assurance, deputy Head of Quality Control

Praxisgemeinschaft für Zelltherapie Duderstadt, GmbH & Co. KG, 

37115 Duderstadt

Additional Qualification

  • Authorisation to work with animal pathogens according to §2 Animal Pathogens Ordinance
  • Expert for auditing, GMP auditor
  • DGQ Quality Manager, German Society for Quality e.V.
  • Quality officer and internal auditor in the healthcare sector
  • Basis ISO 9000:2000, German Society for Quality e.V.
  • Quality management specialist, TÜV

In addition, various further training courses in quality management and GMP

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