Beschreibung
Assay Developer
Reference: 9033KSJM
Industry: Pharma
Location: Zurich area
Start: as soon as possible
Duration: longterm
For our client in the Zurich area we are placing an Assay Developer with a background in diagnostics and experience in new assay product development under a GMP-regulated quality system
The candidate will be part of a product development team and contribute towards the development and commercialization of Diagnostic assays
The candidate will be responsible for:
* Ensuring assay meets product design and performance requirements through successfully conducting verification and validation studies on time and under a project budget
* Authoring and executing reagent verification/validation protocols
* Developing and validating QC testing methods, establishing material specifications and process acceptance criteria
* Working closely with Technology Transfer and Manufacturing team to develop final manufacturing documentation and successfully transferring QC methods and reagent manufacturing processes to a GMP manufacturing environment
* Developing work plans to ensure the timely completion of product development, verification and validation under a quality system
* Conducting process optimization and identifying opportunities for process improvement and control
* The position will require great attention to detail and good problem solving skills
Requirements:
* Experience in the development of Diagnostic assays
* Familiarity/expertise with PCR chemistry and instrument usage
* Demonstrated ability to successfully transfer reagent processes to internal and/or external Manufacturing organizations for approved assays
* Demonstrable experience with PCR amplification technologies, development under a Quality System. Experience in a GMP environment and test method development and qualification
* Work well in a team environment in completing assignments on time to meet project requirements
* The individual must have the ability to handle multiple projects at the same time and work in an interdisciplinary team.
* Good German and English language skills mandatory