Scientist Lab Technician Assay Development

ppbProjekt: /b /p /p Für unseren Kunden, ein grosses Pharmaunternehmen mit Sitz in Rotkreuz suchen wir einen bScientist Lab Technician Assay Development /bpbBackground: /b /p pThe Assay Development team is responsible for the development of molecular diagnostic and screening tests based on PCR technology in the areas of infectious diseases, genomics, and oncology, from early feasibility to commercial launch. Our main areas of responsibility include initial prototyping; optimization of assay design to meet product requirements and ensure manufacturability; development of test methods and acceptance criteria; transfer of reagent manufacturing instructions, test methods, and workflows to Operations; the design and execution of verification and validation activities, including guard-band studies, stability studies, and technical performance verification studies; and documentation of analytical performance for product labeling and regulatory submission packages. Throughout the product development phases, Assay Development interfaces with various departments including Research, Operations, Quality, Regulatory, and Business in order to create and realize what patients need next. /p pbThe perfect candidate: /b /p pGraduate as Biomedical Analyst Scientist (BMA HF) or apprenticeship as Lab Technician (Biology, Medical /p pDiagnostics, Chemistry) or Bachelor / Master degree in Life Sciences (no PhD graduates). Min. 2 years of lab /p pworking experience (ideally in the Mol. Biology / PCR field) with data analyses and biostatistics. Very good MS-Office and documentation skills as well as English fluency. Open-minded and proactive team player. /p pbTasks Responsibilities: /b /p liWorking with high throughput lab – analyzer /li liRoutine lab work with infectious samples and leading of own experiments including the analysis of them /li liPlan and execute different work packages for the development of molecular diagnostics test /li liParticipation in project meetings and presentation of experimental data /li liPrecise documentation of experiments using electronic lab journals according to GMP Standards /li liEquipment handling and maintenance /li liStatistical data analysis using different software and tools (e.g. JMP) /li liAuthor official documents (e.g. Design History Files) /li pbMust Haves: /b /p liGraduate as Biomedical Analyst Scientist (BMA HF) or apprenticeship as Lab Technician (Biology, Medical Diagnostics, Chemistry) or at least Bachelor or Master degree in Life Sciences with practical experience from the Lab (no PhD graduates) /li liIdeally 2+ years of lab experience with data analyses and biostatistics /li liVery good and thorough documentation skills /li liEnglish fluency written and orally is a must, German is a plus /li liOpen-minded team player /li liPro-active mindset and organized working style /li liFlexible, strategic thinking and self-dependent person /li pbNice to Haves: /b /p liLab experience from a biotechnical environment with infectious sample handling Biosafety Level 2 /li liExperience in a GMP/GLP environment ( /li