Motivated and results-oriented biotechnology professional with 20+ years’ experience in CMC (Chemistry, manufacturing and Control) development of therapeutic proteins, cell therapy and small molecules at various development stages.- Work with Regulatory Affairs and Operation teams to develop CMC strategies for product development, regulatory submissions and responses.- Lead CQA (critical quality attributes)’s determination, Analytical Control Strategies development and specifications’ establishment for drug substance and drug product.- Draft CMC sections for submissions and information request responses to the FDA, EMA, Anvisa, SwissMedic and other agencies.- Manage external CMC development programs.