In Werfen, consideration for People is the key factor for success.
You will have the chance to work for a Company leader in the in vitro diagnostics market, with an international appeal, an high-quality interpersonal relationships, a constant attention for people and the opportunity to emerge and grow professionally…those are some of the main elements that characterize the culture of our Company.
We want people to choose to work in Werfen for the environment and for professional growth opportunities which encourage us developing the initiative and innovation.
For our Clinical Chemistry Strategic Business Unit, based in Milan (Italy) we are looking for a:
REAGENTS DEVELOPMENT MANAGER
Key Accountabilities include but are not limited to:
- Study and organize the development of new clinical chemistry and toxicology in vitro diagnostic products and the improvement of those already in production
- For new projects, prepare the project plan in collaboration with the other company departments involved. Agree with them the timing of implementation and participate in the meetings of state projects review to monitor the status.
- Collaborate with the Quality Engineering in the Post Market Surveillance activities (including the analysis of the EQAS) and the definition of any necessary improvement actions
- Coordinate and promote the identification and technical validation of new suppliers of raw materials and OEM IVD products, giving priority to their criticality and the need for a second source
- Supervise the evaluation activities of problems concerning the production and QC.
- Coordinate the development of applications, the verification and validation of their performance in accordance with company protocols and CLSI standards, as well as the drafting of related documentation.
- Coordinate and support direct collaborators in daily problems and pays particular attention to their professional development and their technical and scientific training.
If you have:
- 5-10 years of experience in a comparable position
- Degree in chemical or biological sciences
- High level of expertise in in-vitro diagnostic technologies, preferably in the field of Clinical Chemistry and immuno-enzymatic
- Knowledge of IVD formulations, methods and clinical values (colorimetric, immunological, immuno-enzymatic, ISE)
- Chemical chemistry/ pharma-toxicology diagnostic analyzers operating principles
- Knowledge of laboratory and quality control procedures
- Knowledge of protocols and international CLSI standards and IVD medical device regulation
- Knowledge of statistical processing programs and methods (eg. MedCalc)
- Very good level of written, oral English
YOU ARE THE PERSON WE ARE LOOKING FOR!
Send us your Resume on LinkedIn and join the Werfen Team!