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Celonic is a privately owned Contract Development Manufacturing Organization (CDMO) with two state-of-the-art sites located at Basel, Switzerland (headquarters) and Heidelberg, Germany.

Celonic provides comprehensive GMP development and manufacturing services for New Biological Entities (NBEs) and Biosimilars, as well as Cell & Gene Therapy associated services worldwide. Their portfolio includes the development of cell lines, production processes, as well as non-GMP and GMP manufacturing of biopharmaceutical drug substances and drug product. Currently there are over 300 highly qualified employees working at the two sites of Celonic. Because of the expansion of the company, Celonic is looking for dedicated and qualified employees.

To strengthen our team in Basel (city) we are looking for a new member in the Quality Assurance

Senior Quality Assurance Manager (f/m/d) with life science background 
Focus on Gene and Cell Therapy

Your area of responsibility:

• Quality management in the field of gene and cell therapy: cooperation with employees responsible for compliance


• Definition and promotion of quality standards in assigned customer projects from development to GMP batch


• Support of the continuous development of the company as process expert (f/m/d) for different business processes of the corporate process landscape


• Assumption of responsibility for quality-relevant processes such as risk management or validations


• Preparation of batch release by the QP/FvP


• Quality support for the creation of Master Batch Records


• Creation, review and approval of SOPs, plans and records in the area and in the project


• Processing of deviations, incidents and change control in the area and project


• Support with supplier qualification, self-inspections as well as customer and authority audits


• Promotion of culture and awareness within the company


• Regulatory advice to colleagues on quality issues

Your skills & qualification:

• Successfully completed academic degree in a scientific or medical discipline


• Experience in pharmaceutical quality assurance (GMP, ICH, KVP, ISO)


• Experience in Gene and Cell Therapy (TpT, GT, GMO)


• Very good knowledge of the German and/or English language, written and spoken


• Excellent communication skills


• Strong team spirit and assertiveness


• Working diligently and independently to achieve the agreed objectives

Why Celonic? - We offer:

• Permanent position, full-time


• Flexible working hours


• Responsible and interesting tasks in a forward-looking company


• Professional development opportunities based on individual potentials


• Flat hierarchies, short decision-making paths and the opportunity to contribute your own ideas


• Attractive company fitness program


• Collegial working environment build on respect as well as strong team spirit

Do we have your attention?

We look forward to receiving your application. Please send your application documents, your earliest possible starting date and your salary expectations to Andrea Becker. Preferable we get your application via our application form.

 

Celonic AG

Human Resources

Eulerstrasse 55

CH - 4051 Basel

Tel +41 (0) 61 5649-150

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