vacature kwaliteit

Advanced Therapy Medicinal Products Quality Manager

  • Fulltime
  • Vast
  • Baden, Germany
  • Referentienummer: WN/020-031-DD

Derks & Derks

Become part of an expert group which explores new biopharmaceutical modalities

Offer
  • managerial position within an expert group of professionals
  • leadership position within Biopharma Contract Manufacturing
  • driven and energetic work environment
Organisation

Our client, a leading, international biopharmaceutical company with site in southern Germany, is looking for an Advanced Therapy Medicinal Product (ATMP) Quality Manager. Would you like to become part of an expert group which explores new biopharmaceutical modalities, Advanced Therapy Medicinal Products and extends our client’s manufacturing expertise within the Biopharma Contract Manufacturing Business Unit? Then show us your strong understanding of existing and leading-edge analytical test methods and quality assurance systems in manufacturing of virus-based therapeutics. Take your chance and provide your expertise as key input for operational and strategic decisions regarding future business cases in the field of Advanced Therapies.

Position

As ATMP Quality Manager you provide expertise and guidance to internal functions as well as to external clients in the broad range of quality test methods for viral vectors and therapeutic viruses. Also, you are going to implement robust CMC Compliance Programs covering all aspects of the manufacturing processes, analytical test methods, specifications and shelf live maintenance. You will support technical based discussions during scientific advice with regulatory agencies, drive interactions on quality management processes and lead the technical teams in all quality relevant topics. Furthermore, you will attend and present at conferences.

Profile
  • Masters/Diploma degree or Doctoral degree (PhD) in virology/biologics, biotechnology, pharmacy, or equivalent
  • minimum of three years of professional experience in the field of ATMPs/new biopharmaceutical modalities, preferably in analytical development of cells or viruses for new therapies
  • demonstratable expertise in quality control and/or quality systems required for the manufacturing of viral vectors and therapeutic viruses-based therapeutics
  • in-depth knowledge in the analytical characterization of ATMPs in the areas of drug substance and drug product manufacturing
  • expert knowledge in CMC compliance and biopharmaceutical regulations
  • proven leadership expertise
  • good managerial and social competence (matrix leadership), such as highly developed skills in communication, conflict management together with assertiveness
  • bilingual: fluent in English and one other language. The prerequisite to learn German must be given, preferably already existing basic knowledge
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WN/020-031-DD, to Tim van Loon: info@derksenderks.nl. For further information, please call Tim van Loon at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

Our Client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Tagged as: Life Sciences

Je ontvangt een kopie van dit bericht.