Simone Musiu

Experience

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  GeneWake GmbH

  Apr 2013 - Nov 2015

  Research Scientist

  During my work experience at GeneWake, I was involved in research projects from different fields, from microbiology and molecular biology to immuno-oncology and cancer patient testing. This was an amazing opportunity to broaden up my skills and increase my field of expertise. • I designed, developed and executed 4 in vitro diagnostic Real Time PCR multi-parameter kits (alphaCube) for the detection of viral and bacterial infections in human samples• I was responsible of the design control and process validation program development, as well as documentation redaction of the alphaCube products• I developed DNA/RNA isolation kits for pathogens detection by RT-PCR in food• I managed and coordinated the European FP7-Research Grant TumAdoR based on the screening of more the 2000 new monoclonal antibodies to block tumor growth which led to meeting tight deadline• I developed multiple innovative tissue and blood companion diagnostics strategies to enable or improve a personalized treatment of especially cancer using different approaches• I created new and optimized existing SOPs relating to analytical and diagnostics methods and instrument operation and ensured that the laboratory instruments are operated, maintained, and calibrated to required standards resulting in improvement in efficiency and reduction in instrument downtime by 25%• I supervised PhD students and technical staff, summarized the team’s work and presented results at the European consortium meeting as well as wrote final reports to stakeholdersTechnical expertise: molecular biology, microbiology, genomics, immune-oncology, in-vitro molecular diagnostics, companion diagnostics, biomarker testing, cell culture, multiplex PCR, DNA/RNA isolation, gene expression analysis, clinical laboratory analysis, immunohistochemistry, fluorescence in situ hybridization, project coordination, design of experiments, management of laboratory staff, training of employees, interpreting data, writing reports. Show less

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  Mikrogen

  Jun 2017 - Sept 2017

  Research Scientist

  Temporary assignment in a challenging Zika Virus research project in the R&D Molecular Diagnostics and Innovation Management Department. • I conducted validation and verification activities and produced the kit components of a RT-PCR kit (ampliCube Zika Virus) for detection of Zika virus pathogen, under time and budget constraints • I supervised a master student during the design and initial stage development of a multiplex PCR test for the detection of multidrug-resistant bacterial pathogens• I ensured high quality data analysis and accurate documentation Show less

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  Abionic

  Feb 2019 - Nov 2020

  R&D Project Lead, IVD Development

  I led the allergy development team managing the organization and communication, meeting the deliverables within the timelines, to complete the respiratory allergy IVD tests for the abioSCOPE device.• I managed the development of diagnostic tests in compliance with the internal Quality Management System and under the ISO 13485 standard as well as projects for biological material characterization, reagents optimization, technology assessment and kit stability• I directed the allergy team through projects and product life cycle Design Controls, ensuring the finalization of appropriate documentation to meet the FDA QSR and ISO 13485/IVDR/MDR requirements• I managed the project for IVD test development and/or research and designed the experiments• I guided technical transfer from Production of new products from R&D to industrialization, actively participating in all protocol development and validation phases to ensure compliance with GMP• I led externalized development projects and managed external communication• I controlled the search and acquisition of clinical samples with international brokers• I acted as operational report and mentor to subordinates (e.g. Scientists and Laboratory technicians), as well as participated in duties for the maintenance and organization of the laboratory• I was involved in writing and revisions of scientific publications (peer reviewed articles) internal and regulatory documentation Show less

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  Medidee

  May 2021 - Jul 2023

  QA/RA Project Associate Consultant - IVD Group

  • I provided strategic and tactical regulatory support for IVD devices, including implementation and management of Regulatory Requirements related to IVDR (EU 2017/746) and MDR (EU 2017/745)• I prepared and evaluated Technical Documentations, including Performance Evaluations (PER), according to best practice and regulatory requirements• I provided support for the alignment between claims and their substantiation• I supported the implementation of analytical, clinical performance, and validation & verification activities by writing and/or reviewing plans, protocols and reports• I offered solid expertise during product life-cycle, including design & development process, risk management and post-market surveillance• I implemented and managed QMS based on ISO 13485, supplier management including audits and QA agreements• I sustained manufactures based outside the EU or CH who need an Authorized Representative under MDD, MDR, IVDD, IVDR before placing CE marked medical devices on the EU/CH market• I taught and provided trainings to clients and to CARAQA Certified Program Show less

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  SOPHiA GENETICS

  Sept 2023 - Nov 2023

  Design Assurance Lead - Quality Officer

  • I actively participated to international project teams to develop software as a medical device and IVD devices by providing necessary Quality Systems guidance• I leaded Design Reviews to ensure that all required deliverables are met: reviewed, assessed and approved product design milestones and deliverables across product development cycle to ensure compliance to customer and regulatory requirements• I reviewed QMS documentation to keep with current industry standards• I coached, mentored, and supported of key members of the design and development teams to ensure effective and consistent application of design controls and risk management• I participated in internal and supplier audits as Lead Auditor• I supported the Regulatory Affairs department by conducting IVDD CE-Marked Technical Documentation gap analyses to identify those areas of documentation, procedures, and processes that need to be revised/updated for compliance to the IVDR (EU 2017/746) Show less

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  FIND

  May 2024 - now

  Quality and Compliance Manager