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

Scientist Lab Technician Assay Development (m/w/d) – Molecular / Data analyses / Documentation / GMP / BSL2 / English

Role:

For our client Roche Diagnostic based in Rotkreuz we are looking for a Scientist Lab Technician Assay Development (m/w/d).

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.

Areas of responsibility:

– 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)

Professional and technical requirements:
– 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 Haves:

– Lab experience from a biotechnical environment with infectious sample handling Biosafety

Level 2

– Experience in a GMP/GLP environment

Reference no: 920923

Role: Scientist Lab Technician Assay Development

Industry: Pharmaceutical industry

Workload: 100%

Location: Rotkreuz, Switzerland

Start date: 03.01.2022

Duration: 6++

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.