Lab Specialist und Development Engineer (f/m/d)
Posted on Apr 16, 2021 by ITech Consult
Lab Specialist und Development Engineer (f/m/d) - chemistry/R&D/S2 Lab/GxP/English
For our client Roche Diagnostics in Rotkreuz we are looking for a highly motivated and qualified Senior Lab Specialist und Development Engineer (f/m/d)
BGE System Reagents is a team within the Point-of-Care R&D Sensors, Reagents and Processes Development Department at RDI Rotkreuz. The expertise lies in the development of calibrators, controls, diluents, internal solutions and auxiliary reagents for our BGE instruments. The System Reagents team comprises people with backgrounds in analytical chemistry and material science who have experience in method development and lab-scale reagent production.
The team works in multi-disciplinary projects in different areas: Development of IVD reagents (calibrators, controls, internal solutions) used with BGE instruments, Replacement of raw materials in reagent formulation, Improvement of in-process control and release (QC) test methods, Establishment of reagent specifications and requirements, Evaluation and specification of primary packaging materials, Support of Manufacturing and Regulatory Affairs and providing product care for all system fluids in BGE systems. And the team works in close cooperation with other BGE R&D teams, Operation's Reagent Process Improvement, Reagent Production and Quality Control teams.
Tasks & Responsibilities:
* Development of reagent formulations in a lab-lot scale
. Establishing a pilot scale filling line for reagent production
. Evaluation of the chemical stability, sensor and material compatibility of formulations
. Establishing and maintaining close collaborations with other teams such as system engineering, method development and system testing or external partners
. Analysis of reagents and materials in external laboratories according to standards; evaluation of test results
. Timely and efficient documentation of test results; preparation of test plans and test reports
. Coordination of deliverables and tasks according to timelines
* MSc or PhD in Chemistry, Material Sciences or related sciences
. 1-2 years' experience working in R&D environment
. 1-2 years' experience working in the development of IVD reagents and the assessment of chemical stabilities
. Broad knowledge and hands-on experience in chemical analytical methods (eg HPLC/IC, UV/VIS or IR spectroscopy) with focus on small molecules and ions analysis
. Experience in process development for pilot production scale
. Willingness to work in a S2 lab environment
. Excellent technical writing skills
. Fluent in English, German is a plus
. Excellent communication and collaboration skills - you can cooperate and network with people across R&D, Operations and Quality Assurance. Solution oriented, autonomous and proactive working style
Nice to haves:
* Experience of working in GxP environment
. Knowledge of microbiological control of IVD reagents
. Project management skills
Reference No.: 920222SGRRole: Lab Specialist und Development Engineer
Industry: Pharma Location: Rotkreuz Workload: 100% Start: 01.05.2021 Duration: 12++
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert.
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