top of page
  • LinkedIn

Paula Shadle, PhD

Strategic CMC and Quality Systems Expert

Career Highlights

  • Principal consultant of Shadle Consulting Services, offering strategic CMC consulting and quality systems to biopharmaceutical and pharmaceutical firms seeking efficient and compliant quality systems throughout the product life cycle

  • Helps virtual biopharma firms establish quality systems, develop and transfer CMC processes, and prepare and support international sites for US inspections

  • Facilitates the work of multi-national teams and supports clients with international regulatory challenges

  • Advises firms in Europe, Japan, the USA and Canada  

  • Co-inventor on five process patents

  • Author of more than 30 publications

  • Technical and senior management positions in protein chemistry, cell biology, process development, and QA/QC, at Chiron Corporation, Scios Inc., SmithKline Beecham Pharmaceuticals, Rhein Biotechnology and Bayer Corporation


  • Postdoctoral training: Fellow at the Max Planck Institute for Biophysical Chemistry

  • BS and PhD, Biology: University of California

  • Fluent in German

bottom of page