Elena Kostadinova

• Ensured QA processes were followed to ensure maximum product quality • Developed and implemented a robust quality assurance process to ensure high-quality products

• managed the QA team of the branch & acted as Management Representative of the QMS • lead external audits and management reviews according to ISO 13485 • developed & tracked key performance indicators to measure the effectiveness of the quality assurance program • developed training materials & conduct seminars to ensure that all personnel understood & adhered to quality standards • collaborated with cross-functional teams to develop & implement QA processes that improved product reliability

• internal & external audits for ISO 13485 certification • EHS/OHS representative • responsible for the assessment and implementation of biotechnology-related standards required for the manufacturing of novel rapid diagnostic test for SARS-Cov2 • worked closely the biotechnology development team to define acceptance criteria & verification/validation plan tests following international guidelines and standards • defined risk mitigation measures and requirements for transfer to manufacture processes

• QMB - maintenance of the internal QM system according to ISO 9001 • Lead internal and external audits & staff trainings related to ISO 9001 as well as with local authorities for maintenance of work laboratory certifications (e.g. for work with S2 Level human pathogens & for S2 Level GMO work) • Responsible for product/method validation studies design and planning as well as for the definition of quality objectives & processes (according to AOAC & ISO 16140 standards)

• Established from scratch a Biosafety S2 Level Laboratory & certified it for work with human pathogens and GMO organisms • Technical day-to-day supervision & training of staff/Assay development team management • work closely with technical & business staff in developing ideas into grant proposals • conceptualize and execute high quality written applications, translating highly scientific content into terms that appeal to general scientific reviewers

• responsible for the acquisition and management of grants and subsidies for R&D • involved in the development of a novel technology for real-time bacterial detection

• Studied innate immune responses to bacterial pathogens in the lung • Trained and supervised biology/medical students (ZIBI Summer School) • Presented scientific reports at national and international conferences • Main techniques: primary cell isolation/culture · ECIS · ELISA · DNA/RNA isolation · RT PCR · qPCR · S. pneumoniae culture and infections · microscopy · microbiota analysis · in vivo murine infections

Infection biology, Microbiology, Immunology