Job Description
Management of bioassay projects, including bioassay development and validation, for release and stability testing of biologics following GMP requirements
1. Full responsibility for managing customer bioassay projects for release and stability testing of biologics in the methodological field of cell based and immunological assays
2. Responsible for method development, optimization, qualification/validation including reporting
3. Communication with clients as primary contact
4. Responsible for scientific and technical quality considering GMP requirements
5. Planning and organization of project scheduling
6. Review and approval of data including reporting of data according to GMP
7. Monitoring and ensuring the GMP regulations and compliance
8. Application of electronic tools like eQMS and LIMS
9. Operation and support of analytical devices
10. Supporting and organizing the practical work in the laboratory
Qualifications
11. Successfully completed study (university or college of higher education) in biology, biochemistry, or any related subject, PhD is an advantage
12. A minimum of 2-3 years practical experience in running cell based and/or immunological assays
13. Proven track record in a GMP-regulated environment is an advantage
14. High degree of self-motivation, commitment, and flexibility to provide pro-active interactions with our clients
15. Independently and efficient way of working and willingness to take over management tasks
16. Team player and leader
17. High degree of analytical thinking and good organizational skills
18. Very good user IT skills (MS Office, LIMS databases)
19. Excellent oral and written communication skills in English and good skills in German