Marina Rudisch

Management of (sub-)projects concerning the pharmaceutical-technical transfer and the implementation of robust and capable processes for aseptic filling of vials, cartridges and syringe injection systems from laboratory scale to commercial production in direct contact with international customers.

Deputy Head of Production according to AMWHV§12 for the manufacturing, filling and crimping of an aseptically filled and freeze-dried drug. Ensuring aseptic manufacturing in compliance with EU GMP, US FDA and international laws and guidelines. Resource, cost and production management in compliance with laws and guidelines. Internal supervisor for national and international authority and customer audits. Coordination and implementation of qualifications, performance qualifications and validations.

Contact persons for the quality assurance + quality control + validation department. Organization and monitoring of production processes within the department with the most efficient use of resources. Monitoring of production dates as well as preparation and testing of the associated documents. Ensuring compliance with occupational safety and GMP requirements. Continuous improvement of production processes, cooperation in projects.

Coordinator for all production departements with the aim to get to know the interfaces within the production. Collaboration on site-wide processes as well as on projects within the pharmaceutical production (sterile and non-sterile).

Analyses of 10 human AKR family members for 20beta-reductive activity on steroids: cloning of all human genes of the AKR family, recombinant expression of the AKR family members in HEK293 cells, enzymatic activity tests (via LC-MS and radioactiv via HPLC).

Development for the parallel quantification of 50 eicosanoids at human plasma via LC-ESI-MS/MS: evaluation of solid phase- an dliquid-liquid-extractions, method optimization and validation after FDA quideline, statistic data analyses via R and Analyst.

Cell cultivation, viability and cytotoxicity tests of cells after treatment with chemical substances, characterisation of metabolic steroids and enzymes (molecular biology and protein biochemistry).

Determination of the expression of the enzymes of the 17beta-HSD family and steroid receptors at breast cancer cells (quantification via qPCR).