Aksel Sebastian Lee Møgelvang-Olesen

Primary contact/gatekeeper and coordinator for the testing needs of the Danish life science industry: Bridging their needs with the subject matter expertise and testing capabilities of the vast Eurofins (matrix) laboratory network. I have experience with coordinating a multitude of different testing projects for both medical device and pharmaceutical manufacturers (GMP, GLP): Bioburden/Endotoxin/Sterility Validations, Reprocessing, Packaging, Biocompatibility, E&L, Environmental Monitoring, Stability, Raw Material, Release testing, Elemental Impurities and countless monographs and customized microbiological/Chemical testing projects for the largest life science companies in Denmark. Often overseeing 15-25 ongoing projects at any given time.

• Setting up projects whilst coordinating and collaborating with clients and Eurofins' cross-functional teams and SMEs to ensure continuous alignment, progress monitoring, conflict resolution and achieve testing objectives via smooth project progression.
• Built a vast network of internal and external subject matter experts spanning departments, countries, cultures, companies, associations and regulatory bodies.
• Representative for Eurofins Biopharma Testing across numerous conferences.
• Drafted, negotiated and oversaw service agreements and NDA with partners.
• Developing and executing business plans/strategies for the testing market in Denmark. This also largely entailed active monitoring of the regulatory landscape which was largely a continuation of my Thesis findings.
• Organized workshops for life science manufacturers - Hosted by Eurofins' Subject Matter Experts.

• Investigated the plethora of challenges and trends faced by danish medical device manufacturers in the face of impending MDR implementation: Lacking notified body capacity, product scope expansion and MDR re-classification
• Mapped the Danish Medical Device ecosystem: Identifying relevant stakeholders across the stakeholder spectrum.
• Supported company expansion efforts via both quantitative and qualitative analysis - identifying key drivers and avenues of growth through careful market research and competitive landscape assessments.

• Reviewed, oversaw and implemented changes related to labelling, Instructions for Use (IFUs) across a multitude of Agilent Technologies products to achieve compliance with newly introduced IVDR-Standards.

• I conducted pre-clinical testing on compounds designed as novel DNA repair stimulants: Studied the impact of various compounds on DNA repair using a range of experimental techniques, including Assays, Western Blots, Cell Counting, FISH (Fluorescence In Situ Hybridization), and BAC assays
• Presented the findings at the Basel Life 2018 conference and received recognition by earning second place in the poster competition.