Research and Development Leader for in Vitro

vor 1 Woche


BielBienne, Schweiz Calciscon AG Vollzeit

Calciscon is a fast-growing Swiss medical device company marketing the T50 blood test to positively impact the lives of millions of kidney disease patients worldwide. The T50 is already CE marked, and Calciscon has a pipeline of assays under development to complement its offering in calcification diagnostics. We seek a new team member who can strive in an entrepreneurial environment.

Tasks

Job description
- Design, plan, perform, and document product development activities, including reagent development, assay optimization, and analytical/clinical studies for regulatory filings (IVDR, FDA)
- Troubleshoot experiments, consult literature and actively propose/pursue solutions
- Characterize manufacturing steps for reagents, draft/validate SOP, and train/transfer to team members in QC/manufacturing.
- Operation of conventional biochemistry/IVD instruments and perform bench work
- Work closely with supervisor to meet project deliverables in a timely manner
- Interface with the Calciscon QMS, for compliance with Design Controls
- Other duties consistent with the position

**Requirements**:

- Master’s degree or equal, preferably in biochemistry or closely related fields
- 2+ year working experience in IVD assay development
- Able to work independently and reliable.
- Accustomed to biochemistry wet bench work, and must be willing to handle human specimen (e.g., serum and urine samples)
- Demonstrated analytical, logical and planned approach to problem solving
- Strong writing skills in English, with an excellent capacity to describe concepts, methodology and processes in a clear and concise manner
- Entrepreneurial spirit, with a “I can do it” attitude

The official language of the company is English.



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