Paul Rohlfing is Sr. Director Global Chemistry, Manufacturing, and Controls (GCMC) at Pfizer, supporting vaccines and biotherapeutics. He is accountable for developing and implementing global regulatory strategies to achieve successful product registrations and regulatory approvals for post-approval changes. He was responsible for the development of the technical content for the drug substance portions of global licenses for Prevenar 13 including definition of control strategies and specifications. In his previous role he was responsible for development, scale-up, and transfer of processes related to the protein production and activation and conjugation processes for conjugated polysaccharide:protein vaccines. His career spans more than 25 years in regulatory affairs, process development, validation and production management, including experience with conjugated bacterial vaccines, oral dosage forms, sterile opthalmics, and topical semi-solids at SmithKline, Allergan, Sandoz, Lederle, Wyeth, and Pfizer. He received a BS in Chemical Engineering and completed graduate coursework in Industrial Engineering at the University of Nebraska-Lincoln.