Daniel Schaufelberger, PhD — VP Chemistry, Manufacturing, & Control (CMC)

Daniel is a pharmaceutical executive with 25+ years of experience in pharmaceutical research and development, Chemistry, Manufacturing & Controls (CMC), having served in various project, line, and team leadership/management roles.

Daniel started his career at PRI Inc., a Frederick, MD-based CRO for the US National Cancer Institute, then joined Sandoz Pharma AG, Analytical R&D, in Switzerland. He moved to Johnson & Johnson at CILAG AG in Switzerland before relocating to the US to lead Analytical Development at the R.W. Johnson Pharmaceutical Research Institute and Janssen Pharma R&D. He then transitioned to CMC Project Management, leading CMC project teams, supervising CMC Leaders, and building a CMC Project Management Organization. In his role as CMC Leader, Daniel led global CMC development activities for multiple products through preclinical and clinical phases to successful US/EU filings and launches, representing CMC on international cross-functional teams. He has worked across various therapeutic areas, including CNS, infectious diseases (antiviral, antibacterial, antifungal), and oncology, covering a range of drug products, including oral solid/liquid, topical, and parenteral dosage forms.

At J&J, Daniel was a member of the Pediatric Center of Excellence, co-leading the internal Pediatric Formulation Network. He has led due diligence efforts and has worked on numerous joint development programs, including with companies in Japan. He has considerable experience managing multi-party CMC business relationships, including outsourcing (e.g. API supplies from China), complex multi-company partnerships with large Pharma & Biotech, and Private-Public Partnerships based on a foundation of sound scientific principles and focused on the needs of patients.