Dr. Nadja Langenberg

Technical Lead for assay immunoassay development projects (infectious disease assays, Alinity i platform) Prototype development, stability and verification studies Investigation / Troubleshooting activities Specification setting, assay standardization Management presentations Submission activities (IVDR submissions, FDA submissions) Supervision of lower level scientists / technicians. Project management activities (personal / reagent resources, development of timelines and milestones).

Technical Lead for various immunoassay development projects (infectious diseases and others) Prototype development (Alinity i platform) Performance verification and stability studies Investigation / Troubleshooting activities Specification setting, assay standardization Management presentations Submission activities (IVDR submissions, FDA submissions) Supervision of lower level scientists / technicians. Project management activities (personal / reagent resources, development of timelines and milestones).

Immunoassay (ELISA, Luminex, ARCHITECT) prototyping work for biomarker discovery studies in different disease areas. Supervision of several lower level scientists / technicians. Project management activities (management of personal / reagent resources, development of timelines and milestones).

Biomarker discovery (neurology); Immunoassay prototype development;

Responsible for technical and scientific support for ARCHITECT Toxoplasmosis assays (IgG, IgM & Avidity) including for example: troubleshooting; change control; CAPA; product investigations; project management; working in compliance with quality systems;

Post Doc performing research studies (molecular biology, virology, immunology, cell biology) Projects: Purification and Characterisation of Biotinylated Fusion Proteins Containing Reoviral σ1‐ and HPV16 L2/E7‐Sequences Establishment of an ELISPOT assay for the detections of equine Granzyme B

Completion of PhD thesis with the title: ‚Strategies for the Development of a Second Generation Vaccine against the Human Papillomavirus Type 16‘ (vaccine development; expression, purification and analysis of proteins; immunology; virology; cell biology; evaluation of immune responses in cell culture systems; protein expression in transgenic plants; immunization studies in mice)

Molekularbiologie, Virologie, Immunologie Diploma Thesis in the Research Group of Prof Dr. Martin Müller in the German Cancer Research Center: ‚Production of Papillomavirus‐like Particles (VLPs) and Pseudovirions in Mammalian Cells’