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

Scientist Lab Technician Assay Development (f/m/d) – BMA /biostatistics/German / biosafety level 2/ GMP

Project:
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Scientist Lab Technician Assay Development

Background:
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.

The 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.

Tasks & Responsibilities:
* Performing root cause analysis as part of product care case handling
* 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. Tableau)
* 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 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 solutions
* Strong sense of taking initiative, accountability and ownership
* Self-motivated and independent approach to work with minimal supervision
* Apply creative thinking and adapt to various tasks and changing priorities
* Strong affinity for IT and technology
* 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

Nice to Have:
* Lab experience from a biotechnical environment with infectious sample handling Biosafety Level 2
* Experience in a GMP/GLP environment

Reference Nr.: 923570SGR
Role: Scientist Lab Technician Assay Development
Industrie: Pharma
Workplace: Rotkreuz
Pensum: 100%
Start: 01.09.2024
Duration: 12++
Deadline: 30.07.2024

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:

ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.

We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.