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