CK Science are recruiting for an experienced Quality Manager to join an international Biopharmaceutical company based in Southern Germany. This is an exciting opportunity to become part of an expert group, which explores new biopharmaceutical modalities/Advanced Therapy Medicinal Products (ATMP).
The successful candidate will have a strong understanding of existing and leading-edge analytical test methods and quality assurance systems in manufacturing of virus-based therapeutics.
The Role: Responsibilities of the Quality Manager (ATMP):
- 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.
- 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 characterisation of ATMPs in the areas of drug substance and drug product manufacturing.
- Expert knowledge in CMC compliance and biopharmaceutical regulations.
- Proven leadership expertise.
- Bilingual: Fluent in English and one other language. The prerequisite to learn German must be given, preferably already existing basic knowledge.
- The chance to build a complete new area in a well known company.
- Career development opportunities through internal and external training opportunities.
- Healthy and balanced meals in the staff restaurants.
- Attractive salary.
Apply: For more information or to apply for this Quality Manager position, please contact Naynesh Mistry on 0146 457703 or email email@example.com, quoting job ref 48261.
It is essential that applicants hold entitlement to work in Europe.