OAKLAND, CA, April 02, 2025 /24-7PressRelease/ -- Dr. Paula J. Shadle has been selected for inclusion in Marquis Who's Who. As in all Marquis Who's Who biographical volumes, individuals profiled are selected on the basis of current reference value. Factors such as position, noteworthy accomplishments, visibility, and prominence in a field are all taken into account during the selection process.

Dr. Shadle founded Shadle Consulting Services in 2001, a firm that advised biopharmaceutical companies on product and process development, quality strategy, and quality assurance and control evolution across the research and development life cycle. Co-inventor of five process patents and author of over 40 publications, Dr. Shadle was a collaborative team player who worked on projects from research through commercial development stages. Among her signal contributions was advising and supporting a client on a site change and potency assay change for a marketed product, an effort that spanned two continents and four different firms.

Dr. Shadle's career began with research in protein chemistry at Cetus Corporation (later Chiron), where she worked with a protein extracted from E. coli bacteria and explored various protein forms and their pharmacology. She moved into process and analytical test methods development at Scios Inc., where she was a senior scientist in purification process development. In her subsequent role as department head, she worked on several potential biopharmaceuticals and participated in the firm's first investigational new drug filing.

At SmithKline Beecham, now GSK, Dr. Shadle served in roles of increasing responsibility, including analytical methods development, downstream process development, quality operations, and quality assurance and control. She rebuilt the company's quality group to prepare it for late-stage process development. Additionally, she collaborated with other scientists to develop novel approaches to viral process validation, an expensive regulatory requirement to prove the safety of recombinant proteins.

As a consultant, Dr. Shadle assisted firms of all sizes, advising on compliance strategy and risk management, inspection preparedness, and communication with regulatory agencies on chemistry, manufacturing and control issues. Among her publications are a review article on bovine spongiform encephalopathy, also known as mad cow disease, book chapters on managing investigations into aberrant results in the quality control laboratory, and a text about sourcing raw materials for biopharmaceutical use.

After receiving a Bachelor of Science in zoology with honors from the University of California, Davis, and a Doctor of Philosophy in biology from the University of California, San Diego, Dr. Shadle completed her postdoctoral fellowship at the Max Planck Institute for Biophysical Chemistry. She received the Judith Pool Award for excellence in research and teaching from the Association for Women in Science (AWIS), where she served on the board. She has also held board membership with the Parenteral Drug Association and the Saklan School.

Dr. Shadle retired in 2022 and now lives an active life as a volunteer. She is a UC Berkeley Botanical Garden docent and volunteers with Friends of Sausal Creek and the League of Women Voters. At present, she is working on a memoir and family genealogy project. She is married, has two grown children and two grandchildren, and resides in Oakland, California.

About Marquis Who's Who®:
Since 1899, when A. N. Marquis printed the First Edition of Who's Who in America®, Marquis Who's Who® has chronicled the lives of the most accomplished individuals and innovators from every significant field of endeavor, including politics, business, medicine, law, education, art, religion and entertainment. Who's Who in America® remains an essential biographical source for thousands of researchers, journalists, librarians and executive search firms around the world. The suite of Marquis® publications can be viewed at the official Marquis Who's Who® website, www.marquiswhoswho.com.

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