Fredrik Nilsson

Vice President with extensive experience in drug development, therapeutic antibodies, CMC, protein chemistry, analytical chemistry, purification, mass spectrometry and process development for biologicals. 20 years as Director/Manager, leading groups, sections and departments in target discovery, CMC, process development, analytics and production. Managed activities performed under ICH/EMA/FDA guidelines. Established new functions, optimized team performance, planned and executed reorganisations. Developed and implemented new strategies, policies and SOP’s for development and production of investigational medicinal products, analytical development and testing, purification and formulation development, product characterisation, product/material compatibility studies, Good Scientific Practice, out-sourcing, tech transfer and virus clearance. Project management experience, both in technology development and CMC. Introduced Quality by Design as a tool in CMC projects. Responsible for CMC sections in CTA filings. Participated in Due Diligence procedures and tech transfer of methods and processes. Key words: Protein chemistry, protein purification, CMC, analytical chemistry, therapeutic antibodies, mAb, process development, project management, Quality by Design, team leadership, development of organisations, mass spectrometry, proteomics, risk assessment, risk management, bioanalysis, API, CMC dossier, IMPD, product characterisation, Due Diligence, Tech Transfer, GSP, GLP, GMP.