Senior Scientist | Laboratory Manager | IVD product development | Exosome | IVDR, R&D, Project Management and Scientific Communication | Cell & Gene Therapy // Open for new opportunities. • Senior scientists @Cellcolabs driving preclinical proof-of-concept and model development for a spin-out company within cell therapy. • Experience as Laboratory Manager designing and optimizing IVD product development and quality control processes. • Experience as Senior Scientist driving preclinical drug validation in collaboration with multiple industry partners in Sweden, US and UK. • Postdoctoral Researcher at Karolinska Institutet I am a Senior Scientist at Cellcolabs, a biotechnology company that specializes in stem cell production and therapy. With over 15 years of experience in cell biology and cancer therapy, I have a strong background and passion for developing and delivering high-quality in vitro diagnostic (IVD) products that meet regulatory and compliance requirements, such as the In Vitro Diagnostic Regulation (IVDR). In my current role, I focus on downstream processing and product development of mesenchymal stem cell (MSC) derived (exosomes)-extracellular vesicles (EVs), using my expertise in tangential flow filtration, assay development and validation, cell culture, and exosome biology. I also work as a Reviewer Editor at Frontiers in Stem Cell Treatments, where I provide expert reviews of submitted manuscripts. I enjoy collaborating with external partners and stakeholders, communicating scientific results, and providing customer support. I am driven by curiosity, creativity, and excellence, and I thrive in a dynamic and supportive team environment. Thank you for visiting my profile, and please do not hesitate to connect and contact me at beklemb@gmail.com Skills --> Experienced in IVD product development, IVDR, ELISA kits, large and bench scale production, concentration, and purification of Extracellular Vesicles (EVs) by using tangential flow filtration (TFF) and bind elute size exclusion chromatography (BE-SEC/ ÄKTA) (Upstream and downstream processing of biomolecules), characterization of EVs, Cell/EV scale-up in 2D and 3D cultures, bioreactor-based stem cell or primary cell culture, shaking incubators adapted to mammalian cell culture, in vitro cell- based assays, molecular techniques such as transduction, transfection, cloning, PCR, qPCR, western blot. -->Project Management, Assay Development, Product Management, Tech Transfer, IVDR, Quality Control, regulatory affairs, communication, documentation, customer relations, scientific writing & editing and presenting skills, writing grant applications.