Your Role:

  • Management and development of all Quality Control Teams (more than 80 employees worldwide)
  • Direct the development, planning, implementation and maintenance of mainly Cell-, FACS- and PCR Quality methods, processes and operations for new or existing products and / or technologies throughout the Miltenyi Biotec QC teams
  • Drive and implement measures to improve process excellence and digitalization based on Process Analytical Technologies
  • Ensure product quality in collaboration with the manufacturing teams and Quality Assurance (QA) for all our products including medical devices, in vitro diagnostic products (IVD), cell based drugs, research reagents and, in cooperation with the engineering departments, of disposables and instruments
  • Ensure regulatory compliance (cGMP, ISO 13485:2016, ISO 9001:2015) in collaboration with the Manufacturing-, Regulatory- and Quality Assurance teams

Your Profile:

  • You have successfully completed your degree in chemistry, biology or pharmacy and bring along exceptional leadership and communication skills, distinctive analytical capabilities and a broad technical skill set, especially in cell-based technologies
  • You do possess a proven track record of experiences in  Cell-, FACS- and PCR Quality methods, alternatively in -omics methods
  • You are committed to solutions and results and bring a proven ability to manage projects to milestones within timeline, quality requirements and budget
  • You have several years of industry experience in leading a mid-size or large quality control team and profound experience with medical devices and/or cell and gene therapy medicinal products and/or in the pharmaceutical industry as QC Manager
  • Ideally, you bring along profound experience in biological sciences, analytical assay development its validation, preferably of cell-based assays or modern biotech based pharmaceutical analytical methods
  • You have solid knowledge and operative understanding of working with quality systems, e.g.: of cGMP, ISO 13485 or ISO 9001
  • You are familiar with quality control software solutions (LIMS, SAP) and are familiar with PAT

What we offer:

  • Flexible working hours for a family-friendly career
  • Personal and professional development in our in-house academy
  • Intercultural and cross-border collaboration
  • A modern workplace and a role you can help shape
  • Short communication lines and a collegial company culture

Who we are:

  • Our innovative solutions in the area of biomedical research and biomedicine make us a pioneer for the therapy of serious diseases
  • Today we are an interdisciplinary team of about 2000 employees
  • Based in Germany near Cologne and with 14 additional, international locations we are a multicultural team
  • We develop innovative cell and gene therapy solutions – together, we want to make cancer history

Contact us:

Miltenyi Biotec GmbH
Benjamin Malik
HR Specialist | Talent Acquistion
Friedrich-Ebert-Straße 68
51429 Bergisch Gladbach
Phone: +49 2204 8306-2430
www.miltenyibiotec.com