You will be responsible for contributing to the implementation of experimental design and data interpretation for the development, validation, and maintenance of clinical assays to detect and quantify biomarkers, in collaboration with designated statisticians and senior scientists. You will be responsible for the operational and technical management of assays, supporting one or several vaccine projects with a limited number of technologies, in collaboration with the assay owner.
Main responsibilities:
- Ensuring assay history files are properly maintained and assay analytical plans, raw data and statistical reports are stored in sustainable systems and tools.
- Supporting internal activities related to assay development and validation, assay maintenance, monitoring and troubleshooting of assay issues and risks, in collaboration with the clinical read-out laboratory.
- Supporting external laboratories for assay quality during development, assay transfer, validation, & testing phases.
- Providing technical support to projects and to the cost effectiveness of Vaccine CL&AP.
- Contribute to the development of expertise, the implementation of improvements in clinical laboratory processes, of state-of-the-art or innovative solutions in assay technology within the operational platform while giving special attention to assay quality and testing performance.
- Ensuring all activities under your responsibility are performed in compliance with Quality Assurance (QA) guidelines, relevant regulations, and internal policies.
- Holding a PhD in sciences or equivalent acquired through professional experience (Biology, Microbiology, Immunology, Biotechnology, Pharmacy orientation).
- Possessing at least 5 years of solid experience in assay development.
- Demonstrating scientific expertise in Biology and technology including automation.
- Having good knowledge of analytical techniques.
- Having good experience in statistics is a plus.
- Fluent communication skills in French and English.
- A full-time (40hours/week) Monday – Friday job.
- A Permanent contract with flexible working hours.
- Work in a fast-growing international organization.
- Meal Vouchers 8 Euro/Working Day.
- Eco-Cheques +/- 250 Euro/Year.
- DKV Hospitalization insurance.
- Additional 12 ADV days.
- A company well-being program targeting both mental and physical well-being.
- A fantastic team with monthly team lunches, fun teambuilding activities (laser tag, escape rooms, sports, etc.) and above all; a great collaborative international work environment
- Personal development through learning on the job and additional trainings.
