Praktikum in der analytischen Entwicklung und Qualitätskontrolle, Schwerpunkt Analytische Ultrazent

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The Position

Your Department and Team:

The Analytical Development and Quality Control (ADQC) unit is located in the Gene Therapy Development Center (GTDC) in Penzberg, Germany.

The ADQC department consists of 40 - 50 persons working to develop and implement novel analytical technologies for pre-clinical studies until market authorization and launch of gene therapeutic modalities.

The sub-team focusing on analytical ultracentrifugation (AUC) technologies consists of one subject matter expert (SME) and one part-time analyst.

We are looking for a highly motivated scientist (m/f/d) with a specific focus on/ or interest in analytical ultracentrifugation technologies for the testing and characterization of gene therapy vectors.

Key Responsibilities:


* Scouting, evaluation, development and implementation of innovative, cutting edge analytical ultracentrifugation technologies and workflows for the analysis and characterization of viral vectors (predominantly rAAV) for gene therapeutic applications


* Driving and advancing the science to characterize and quantify viral vectors with a highly enthusiastic and agile, interdisciplinary team


* Independent, self-organized hands-on execution of experiments: method development, equipment qualification and assay validation under GMP requirements as well as testing


* Contribution to the development and definition of control and testing strategies for gene therapy vectors (e.g.

rAAV payload, full/ empty ratio, process related impurities)


* Independent interpretation, evaluation, and documentation of data and the generation of analytical reports in accordance with current regulations

Who you are:


* You have a track record and knowledge (theoretical as well as hands-on) in analytical ultracentrifugation technologies such as e.g.

MWL-AUC method, operating Optima-AUC, UltraScan, Sedfit software solutions, as well as developing and applying respective IT and data management tools


* You have knowledge in the area of gene therapeutic modalities (AAV, Lentiviruses, etc.).


* You have knowledge and experience with principles of GMP (e.g.

data integrity, equipment qualification, assay validation)


* You have a high degree of self-motivation, responsibility, result-orientation and you are an excellent team player


* You are fluent in English and German language skills (written and spoken)

Advantages:


* Flexible time management


* 2092 Euro salary per month for a full-time internship > 3 months


* Reduce...