You will be part of the Assay Development and Qualification team developing assays used by internal and external parties such as Contract Research Organizations (CRO’s). You will work closely together with technicians to develop and qualify assays for non-clinical and clinical trials enabling registration of new therapeutic products. In order to achieve this you keep yourself up to date with latest development in the field, such as novel technologies, requirements for regulatory documents. You share knowledge with a group of scientists to keep the department fully up-to-date on the latest news and developments in the field. You will collaborate with CRO’s, transfer methods and write protocols. Additionally you record scientific results in publications, regulatory documents, product development records and eventually in patents.
You develop and qualify immunological and cell biological assays (e.g. ELISA and Cell biological assays)
You work hands-on and closely together with technicians within the department (~50% of your time)
You will write necessary documentation and transfer methods to external parties (CRO’s)
You will check compliance with regulations, GXP and FDA regulations
You act as a primary contact for external parties (validation, questions, analysis)
You will keep the department up to date with the latest relevant scientific information regarding immunology, cell biological assays and additionally regulatory documents.
Skills & Experience
A finished PhD degree and at least two years relevant experience in assay development and qualification as either a postdoc or scientist.
You have experience with the development of immunological and cell assays and generation of quantifiable results.
You have experience in assay development to evaluate unwanted immunogenicity.
You have experience with GLP and understand regulatory requirements.
You like to work hands on and combine practical with administrative work .
You are able to work with tight deadlines.
You have excellent relational and communication skills in English (Dutch is an advantage, but not required).
You are eligible to work in the Netherlands without the requirement of applying for a permit.
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