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Manager Manufacturing (m/f) Development and Manufacturing of Clinical Trial Samples - Germany
Posted on : 10 April 2017
- Everyone achieves greatness at our company.
- As one of the most rapidly growing biotechnology companies in Europe, we’re working on revolutionary approaches in the fight against cancer and other diseases.
- Over 500 dedicated, passionate pioneers achieve sensational success and promising breakthroughs time and again by forging new paths – and ensure people all around the world have hope for the future.
- You too can become a pioneer! Here, you’ll achieve greatness.
- Your work will enable the application of our brand-new immunotherapy processes.
- At our company you will be responsible for providing samples for testing of new cancer treatment vaccines in clinical trials.
Your duties in detail:
- You will be responsible for the GMP-compliant production of pharmaceutical kits for our clinical studies. This includes ensuring that our patient-specific products are produced and stored in accordance with relevant manufacturing instructions.
- You will also coordinate production orders, respond flexibly to new demands and accompany the process all the way from production to packing and delivery.
- Similarly, you will prepare manufacturing instructions and operating procedures, process deviation reports and initiate change controls and CAPA measures.
- Working closely with the formulation department and project management, you will support the development of new test sample kits for future studies.
- You will also ensure that qualification and maintenance intervals are adhered to, thereby guaranteeing the functionality of our equipment and GMP facility.
- Moreover, you will monitor suppliers and contract manufacturers.
What you have to offer.
- Doctorate in pharmacy/natural sciences or a degree with professional experience in the production of pharmaceutical agents or end products under GMP conditions
- Experience in the areas of production planning, packaging, warehousing or logistics would be advantageous
- Confidence in ability to prepare manufacturing instructions and standard operating procedures (SOPs) in German and English
- Organizational talent, highly quality conscious and responsible, and willingness to assume managerial responsibilities