Bianca Johansen Email & Phone Number

Clermont-Ferrand, Auvergne-Rhône-Alpes, France

Clermont-Ferrand, Auvergne-Rhône-Alpes, France

Issoire, Auvergne-Rhone-Alpes, France

Regulatory affairs department:- Transition of the technical files to the new medical device regulations (35 devices that become class IIa & IIb)- In charge of writing clinical evaluation reports (CER; MEDDEV 2.7/1 rev4, MDCG 2020)- In charge of writing biological safety evaluation reports (BSER; ISO 10993)- Risk management (NF EN ISO 14971 :2019 in progress)- Validation of customer packaging- Active participation in customer in client, internal, and notified body audits R&D department:- Development Manager- Management of outsourced studies (analytical, in vitro, in vivo)- Data analysis, interpretation, and report writing- Editing scientific reports in response to audits, NC, OOS- Presentations of pre-clinical and clinical results to clientsQuality department:- Drafting of regulatory procedures- Cleaning validation process- Validation report of new equipment

Clermont-Ferrand Area, France

Working as head of R&D laboratory of microbiology at SETUBIO. In charge of the laboratory (equipment), internal projects (valuing our own research), and external projects (working with Pharmaceutical industries and feed/food industries). Closely work with partners and customers to assist them in developing research strategies depending on their needs, and leading their project by managing the laboratory team ( 3 to 5 technicians and engineers) to perform microbiological essays and to develop new methods and tools, with respect to international standards. Expert in the characterization of new prebiotics, probiotics and antimicrobials (& impact on the microbiome), using in vitro microbiological material and methods: Bacteria, fungi, parasites, microalgae, cell culture, cytotoxicity testing, HTS, MI/BC, Time-Kill, biofilms, liquid/solid cultures on inert and cellular matrix…

France

During my training in the R&D department, I have developed my expertise on different microbiological materials: - Bacteria (over 60 genii used, aerobic and anaerobic, planktonic and biofilms), - Microalgae (SETUBIO owns a collection of 150 microalgae), - Parasites (protozoa), - Eukaryote cells (cells culture, cytotoxicity assays, coculture with microorganisms…)And on many in vitro methods to screen or to specifically characterize the activity of natural extracts or synthetic compounds (mixtures or simple molecules): absorbance curves, viable cell count, CMI/B, biofilm studies…

Denmark

During my training in the R&D department of feed application (internship), I have worked on the probiotic properties of a bacteria strain by:- Optimizing protocols of molecular biology such as PCR and Electrophoresis- Performing antibiotic susceptibility tests- Developing novel in vitro experiments

France

Working in the Flavour Division.Assignments and skills:- Coordinate a method to follow the evolution of the aging of aroma products. - Develop a database in VBA (on Excel) used to register products, and follow their aging in R&D of the aroma department.

United Kingdom

Working in the Department of Molecular Biology on a database project of microRNA expression patterns in Xenopus leavis, at various stages of development by:- Using wholemount in situ hybridisation (LNA probes)- Cryosectioning to follow expression patterns

Doctor, Life Science

PhD student, associated to the University of Lorraine. Working on the Antimicrobial potential of natural bioactive compounds

Master'S Degree, Advanced Project Management

By taking the e-learning courses: - Converting strategy into action - Executing complex programs - Leadership for strategic execution.

Master'S Degree, Biological/Biochemical/Biosystems Engineering

Bachelor'S Degree, Cell/Cellular And Molecular Biology

Bachelor'S Degree, Cell/Cellular And Molecular Biology, 67,5