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