Management of bioassay projects including bioassay development and validation for release and stability testing of biologics following GMP requirements
Full responsibility for managing customer bioassay projects for release and stability testing of biologics in the methodological field of cell based and immunological assays
Responsible for method development optimization qualification / validation including reporting
Communication with clients as primary contact
Responsible for scientific and technical quality considering GMP requirements
Planning and organization of project scheduling
Review and approval of data including reporting of data according to GMP
Monitoring and ensuring the GMP regulations and compliance
Application of electronic tools like eQMS and LIMS
Operation and support of analytical devices
Supporting and organizing the practical work in the laboratory
Qualifications Successfully completed study (university or college of higher education) in biology biochemistry or any related subject PhD is an advantage
A minimum of 2-3 years practical experience in running cell based and / or immunological assays
Proven track record in a GMP-regulated environment is an advantage
High degree of self-motivation commitment and flexibility to provide pro‑active interactions with our clients
Independently and efficient way of working and willingness to take over management tasks
Team player and leader
High degree of analytical thinking and good organizational skills
Very good user IT skills (MS Office LIMS databases)
Excellent oral and written communication skills in English and good skills in German
Key Skills Project Management Methodology, Project / Program Management, Construction Estimating, Construction Experience, PMBOK, Visio, Construction Management, Project Management, Project Management Software, Microsoft Project, Project Management Lifecycle, Contracts
Remote Work: No
Employment Type: Contract
Vacancy: 1
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