Qualified person - Germany
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- 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
- As a part of our lighthouse project, you will soon take the next critical step with us.
- With our company , you will become a worldwide forerunner in the development of a completely new type of immunotherapy against cancer using individualized tumor vaccines.
Your duties in detail:
- You will be responsible for the certification of medicines for new therapies (including ATMPs - advanced therapy medicinal products) as part of our clinical trials produced according to our manufacturing authorization pursuant to Section 19 AMG (Medicinal Products Act).
- Moreover, you will handle the regulatory classification and scientific assessment regarding innovative concepts of individualized cancer immunotherapy.
- In addition, you will ensure the continuous improvement of an efficient system for reviewing batch records, deviation assessment and processing, as well as batch certification relating to the challenge of patient-specific single batches.
- Last but not least, you will form the interface between multidisciplinary teams.
What you have to offer.
- Pharmacist, chemist, biochemist, or biologist with the qualification for the knowledge of medicinal products of novel therapies
- Knowledge of the regulatory requirements for novel therapeutics especially for the parenteral application of biomacromolecules and 'nano medicines'
- At least 5 years of experience in manufacturing, quality control or quality assurance of drugs, preferably in the field of ATMPs
- Preferably, experience with GMP-relevant data base systems (e.g., Trackwise) and eBR
- Reliability, flexibility, quick comprehension ability, outstanding communication and assertiveness skills, technical understanding as well as the ability to quickly familiarize yourself with new situations