Friederike Born

I developed a microfluidic infection model for PK/PD studies with high translational relevance. I managed the full project lifecycle, including conceptual design, technical implementation, process optimization, analytical validation using quantitative and qualitative analytical methods for biological and biochemical readouts, data analysis, and structured scientific documentation.

- Responsible for all Ecogen-related activities (BSL-2 pathogens, cell lines, untested human blood) and regulatory applications. - Conducted internal biosafety audits and maintained SOPs, risk assessments, and safety documentation. - Supported implementation of a new BSL-2 lab and coordinated approvals with ETH Zurich, BAFU, and BAG.

ISO 9001/13485 QMS, ISO 19011 auditing, MDR/IVDR regulatory frameworks, ISO 14971 risk management, CAPA, validation, post-market surveillance, supplier management, digital compliance, Lean process improvement, GxP, EU GMP (EudraLex Volume 4), FDA cGMP (21 CFR Parts 210/211) and AMG

Biosystem Science and Engineering (D-BSSE), Bioanalytics "A Microfluidic Hollow Fibre Infection Model for Monitoring Bacterial Growth and Conducting Antibiotic Pharmacokinetic/Pharmacodynamic Studies"

Mikrobiologie, Medizinische Biologie, Molekularbiologie, Neurobiologie/Tierwissenschaften