Scientist Lab Technician Assay Development
m / f / d)
Freelance / temporary employment for a project Zug Start date : asap Reference number : 775319 / 1
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- The 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 ;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 perfect candidate : Graduate as Biomedical Analyst Scientist (BMA HF) or apprenticeship as Lab Technician (Biology, Medical Diagnostics, Chemistry) or Bachelor / & Master degree in Life Sciences (no PhD graduates). Min. 2 years of lab working experience (ideally in the Mol. Biology / PCR field) with data analyses and biostatistics. Very good MS- Office and documentation skills, strong affinity for IT and technology as well as English fluency. The ideal candidate will take ownership and accountability to independently complete tasks. Open-minded and proactive team player.
Responsibilities
Performing root cause analysis as part of product care case handlingWorking with high throughput lab – analyzerRoutine lab work with infectious samples and leading of own experiments including the analysis of themPlan and execute different work packages for the development of molecular diagnostics testParticipation in project meetings and presentation of experimental dataPrecise documentation of experiments using electronic lab journals according to GMP StandardsEquipment handling and maintenanceStatistical data analysis using different software and tools ( Tableau)Author official documents ( Design History Files)Profile
Graduate 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)Apply strong analytical thinking to assess problems and develop solutionsStrong sense of taking initiative, accountability and ownershipSelf-motivated and independent approach to work with minimal supervisionApply creative thinking and adapt to various tasks and changing prioritiesStrong affinity for IT and technologyLab experience with data analyses and biostatisticsVery good MS-Office and documentation skillsEnglish fluency written and orally is a must, German is a plusOpen-minded team playerBenefits
A very renowned companyYou will work in an international environment