Multi-Project Manager (m/w/d) - Diagnostics (Dx)
Location
Hennigsdorf | Germany
Job description
4TEEN4 Pharmaceuticals GmbH is developing a novel approach for the diagnostic and treatment of life-threatening diseases related to acute circulatory failure, which is caused by an enzyme circulating in the blood (DPP3). The lead candidate to neutralize this enzyme is a humanized, therapeutic antibody, which is currently in preclinical development at 4TEEN4. In addition, 4TEEN4 is developing diagnostic tests to detect serious systemic diseases associated with DPP3.
To complete our team in Hennigsdorf near Berlin, we are looking for a
Multi-Project Manager (m/w/d) - Diagnostics (Dx)
Your key responsibilities: - Support in setting up and optimizing of an electronic IVD-R-compliant QMS in close coordination with the Quality Assurance department
- Documentation of quality-related processes and activities, as part of the Dx development
- Implement, update, and develop SOPs in close cooperation with other relevant departments
- Writing, reviewing, managing and archiving quality documents
- Conception and performance of IVD-R workshops within 4TEEN4
- Oversight and coordination of external suppliers for feasibility studies, of development and production of critical raw materials, of reagents and assays
- Familiarity with the scientific background of QM-Processes
- Deputy for the Head of Diagnostics
Your profile: - University degree in pharmacy (B. Sc., M. Sc., PhD), natural sciences or related field
- Professional experience (min. 3 years) in a similar position in diagnostics and/or medical devices
- Well-rounded knowledge of regulatory guidelines (especially IVD-D and IVD-R as well as MPDG)
- Fluent writien and spoken German and English skills
- Experience with ISO 13485, ISO 9001 and associated standards such as technical documentation, risk assessment, performance assessment is a plus
- High multi-project affinity
- Independent and solution-oriented working style
We offer: - An exciting, permanent job in a company focused on the development of innovative therapeutics and diagnostics in an international environment
- A high degree of freedom and responsibility as well as a highly motivated and dedicated team who will support you
- Open and dynamic structure as well as flat hierarchy with short decisions paths
- A remuneration appropriate to the skills and knowledge associated with the job
- Flexible working hours and the possibility for mobile working
Have we caught your interest, and do you recognise yourself in the profile? Then we look forward to receiving your application with all relevant documents (cover letier, CV, certificates, degrees, etc.), including the earliest possible start date and your salary expectations, at
[email protected] .
Contact 4TEEN4 Pharmaceuticals GmbH
[email protected] Tanja Jaquenoud
Human Resources Manager
Neuendorfstrasse 15a
16761 Hennigsdorf
Tel: 03302 - 866 885 0
Website: 4teen4.de
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