Overview

Company
Our client a leading, international biopharmaceutical company with site in southern Germany (Baden-Württemberg) is looking for an ATMP Quality Manager.

Your tasks
Would you like to become part of an expert group, which explores new biopharmaceutical modalities / Advanced Therapy Medicinal Products (ATMP) 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.

Tasks & responsibilities

  • 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
  • Implement robust CMC compliance programs covering all aspects of the manufacturing processes, analytical test methods, specifications and shelf life maintenance
  • Support technical based discussions during scientific advice with regulatory agencies, i.e. EMA and FDA.
  • Drive interactions on quality management processes and lead the technical teams in all quality relevant topics with  industrial customer clients in development and manufacturing
  • Give guidance in preparing and submitting variations and market authorisation applications at different regulatory authorities, i.e. EMA or FDA
  • Attend and present at conferences

Your profile

  • Masters/Diploma degree or Doctoral degree (PhD) in virology/biologics, biotechnology, pharmacy, or equivalent
  • Career changers e.g. from the animal health sector are welcome
  • Minimum 3 years of professional experience in the field of ATMPs/new biopharmaceutical modalities, preferably in analytical development of cells or viruses for new therapies
  • Demonstrated 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 coupled with assertiveness
  • Bilingual: Fluent in English and one other language. The prerequisite to learn German must be given, preferably already existing basic knowledge

Application/information
https://www.ageneo.de/jobborses/586/advanced-therapy-medicinal-products-(atmp)-quality-manager-(m/f/d)/