Erik Steffensen

I have 25 years of leadership experience and domain expertise within R&D, Manufacturing, Supply Chain and Quality of biotech products, biopharmaceutical medicines and medical devices.Worked as both line manager, project manager and specialist in Development, Manufacturing and Quality. Productivity has been increased by the use of the lean methodology. Solid experience within digitalisation and automation including introduction of robots.Extensive experience interacting with health authorities. Have both prepared regulatory strategies and been involved in preparing the underlying scientific reports and regulatory documents. Furthermore, participated in numerous authority inspections.Involved in many development projects thus having thorough knowledge of the drug & device development process covering Target Product Profile, Lead Candidate Selection, clinical trials, product & process development, manufacturing process design, validation and regulatory submission.Part of industry expert group providing guidance within development and manufacturing of cell and gene therapies.Advisor for startups within life science, biosolutions, industry 4.0, fermentation and foodtech. I can help with product & process development, business model design, strategy, business development, leadership and fundraising.