Scientist Lab Technician Assay Development (m/w/d)
Posted on Jan 14, 2021 by ITech Consult
Scientist Lab Technician Assay Development - IVD/English/Excel/Biology/GxP
For our partner Roche Diagnostics in Rotkreuz we are looking for a highly motivated and qualified Scientist Lab Technician Assay Development
The Assay Development team is responsible for the development of diagnostic and screening tests, 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.
- Plan and execute different work packages for the development of diagnostics test according to ISO 13485
- Complex statistical data analysis using different software and tools
- Working with high throughput lab - analyzer
- Participating in project meetings
- Author official documents (eg Design History Files)
- Participates in routine lab maintenance, lab safety and ISO
- Track laboratory inventory (eg equipment, supplies, specimens, raw materials, reagents)
* At least a apprenticeship as lab technician (Biology, Medical Diagnostics, Chemistry)
. Very Good MS Office and documentation skills
. Experience with data analyses (eg Excel)
. Basic understanding in molecular biology or Invitro Diagnostics
. Work experience as a scientist is a plus
. Good technical knowledge
. Experience in a GxP environment Soft skills:
* Open-minded person
. Flexible, strategic thinking and self-dependent person
. Hepatitis B vaccination Not required:
We are NOT searching for someone with a PhD degree.
Fluent in English and German
Reference No.: 919956SGRRole: Scientist Lab Technician Assay Development
Industry: Pharma Location: Rotkreuz Workload: 100% Start: 16.02.2021 Duration: 6++
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert.
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.