Scientist Lab Technician Assay Development (m/f/d)

Scientist Lab Technician Assay Development (m/f/d) – biostatistics / BSL2 / GMP / Molecular Diagnostics / English

Projekt:
Für unseren Kunden Roche Diagnostics International AG mit Sitz in Rotkreuz suchen wir einen Scientist Lab Technician Assay Development (m/f/d)

Hintergrund:

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 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.

Hauptaufgaben und Verantwortungsbereiche:
* Working with high throughput lab – analyzer
* Routine lab work with infectious samples and leading of own experiments including the analysis of them
* Plan and execute different work packages for the development of molecular diagnostics test
* Participation in project meetings and presentation of experimental data
* Precise documentation of experiments using electronic lab journals according to GMP Standards
* Equipment handling and maintenance
* Statistical data analysis using different software and tools (e.g. JMP)
* Author official documents (e.g Design History Files)

Must Haves:
* Graduate as Biomedical Analyst Scientist (BMA HF) or apprenticeship as Lab Technician (Biology, Medical Diagnostics, Chemistry) or at least or Bachelor or Master degree in Life Sciences with practical experience from the Lab
* Min. 2 years of lab experience with data analyses and biostatistics
* Very good MS-Office and documentation skills
* English fluency written and orally is a must, German is a plus
* Open-minded team player
* Pro-active mindset and organized working style
* Flexible, strategic thinking and self-dependent person

Nice to have:

• Lab experience from a biotechnical environment with infectious sample handling Biosafety Level 2
  * Experience in a GMP/GLP environment

Referenz Nr.: 922458TP
Rolle: Scientist Lab Technician Assay Development (m/f/d)
Industrie: Pharma
Arbeitsort: Rotkreuz
Pensum: 100%
Start: 01.04.2023
Dauer: 12++
Bewerbungsfrist: 07.03.2023

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