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With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.
In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.
Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
For our site in Pfaffenhofen/Ilm we are seeking highly qualified candidates to fill the position:
Bioprocess Specialist (m/f/x)
- limited to 2 years –
As a Bioprocess Specialist (m/f/x) you will be responsible for the processes and equipment for the new BioDS building. You will work in a dynamic team for the implementation of new production processes for monoclonal antibodies, as well as their purification and analytics for the commercial and CTM production from Daiichi Sankyo.
- You will perform upstream processing & downstream processing steps in the Test & Trainings Center (fermentation (fed-batch and perfusion), (tangential flow) filtration, ac-id precipitation, preparative chromatography, virus inactivation, ultra/diafiltration)
- You will be involved in the correct procurement, installation, qualification and validation of bioprocess equipment according to GMP guidelines
- You will be involved in the coordination with the project team and different departments, e.g. quality management, engineering, procurement
- You will be involved in the coordination with different external companies, e.g. general planning company, subcompanies and vendors
- You will contribute to establish a new hygienic concept including monitoring plans
- You will be involved in process transfer activities, as well as PQ activities
- You will work in a regulated manufacturing GMP environment and contribute to its maintenance (e.g. organization of equipment and laboratory maintenance, writing and review/approval of SOPs, Master Batch Records and process equipment recipes, maintenance and supervision of hygiene concept; Management and procurement of long-lead manufacturing consumables)
- You will contribute to the preparation and review of qualification and validation documentation as well as the processing of deviations and changes
- You are responsible for the independent establishment and optimization of biotechnological process steps in the upstream and downstream area as well as for the optimization of production flows
- You will be involved in regular reporting to and communication with Japanese collaboration team
- University degree in biotechnology or comparable
- Sound knowledge and several years of experience in the cultivation, fermentation and purification of mammalian cells, as well as the handling of single-use systems (ideally in a biopharmaceutical company)
- GMP experience is an advantage
- You have a fast comprehension
- You are self-reliant and show initiative
- You work carefully with a high degree of reliability and sense of responsibility
- Hands-on mentality
- Required language skills: German (very good written and oral skills) English (very good spoken and written skills)
- IT skills: Microsoft Office applications
- Excellent Benefits
- Growth and Development
- Health and Wellbeing Support