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

Scientist Lab Technician Assay Development – IVD/English/Excel/Biology/GxP

Project / Role:
For our client Roche Diagnostics in Rotkreuz we are looking for a highly motivated and qualified Scientist Lab Technician Assay Development

Background:

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.

Main Tasks

• 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 (internal developed tools e.g. JMP)
  * Working with high throughput lab – analyzer
  * Participation in project meetings with assignment of tasks and completion
  * Author official documents (e.g Design History Files)
  * Routine Labwork with infectional samples and leading own experiments including the analysis of them
  * Analyse samples with Documentation regarding GMP Standards
  * Equipment handling and maintenance
  * Data analysis and Documentation with Microsoft Office and internal Tools

  Professional requirements:
  * Apprenticeship as Biomedical Analyst or Lab Technician (Biology, Medical Diagnostics, Chemistry) with at least 2 years of lab experience or Bachelor or Master degree in Life Sciences with practical experience from the Lab.
  * Min 2 – 3 years Lab experience from a biotechnical environment with infectious sample handling experience
  * Very Good MS Office and documentation skills
  * Experience with data analyses (e.g Excel)
  * Good technical knowledge with experience in biostatistics is a plus
  * Experience in a GMP/GLP environment is a plus
  * English fluent is a MUST and German is a plus

  Soft skills:
  * Open-minded person with an interest in numbers and data analysis
  * Flexible, strategic thinking and self-dependent person
  * Teamplayer
  * Hepatitis B vaccination

Not required:
We are NOT searching for someone with a PhD degree.

Reference No.: 920558SGR
Role: Scientist Lab Technician Assay Development
Industry: Pharma
Location: Rotkreuz
Workload: 100%
Start: 16.09.2021
Duration: 6++
Deadline: 20.08.2021

Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs@itcag[dot]com.

Contact us for further information regarding our company, our positions or our attractive payroll-only-program: +41 41 760 77 01.

About us:

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.