Sheila G. Magil, Ph.D., Senior Consultant, has over 20 years of experience overseeing quality and developing manufacturing processes and analytical methods for biologics, peptides, and small molecules.
She currently provides support to clients in directing external CMC development of new biotherapeutics, developing and implementing phase appropriate quality systems, and preparing CMC regulatory documents. Dr. Magil also supports clients in the areas of analytical development, quality control, and quality assurance as well as performing GxP compliance audits.
Prior to joining BPTC, Dr. Magil was Senior Manager, Analytical Development and Quality Control at Biomeasure, where she was responsible for creating the company’s Biologics Quality Control department and managing external analytical testing and quality control for a biologic product under development.
As Vice President at Waratah Pharmaceuticals, Dr. Magil managed external process development and production of both peptide and protein therapeutics and also developed the analytical testing methods to support formulation and release.
At Alkermes, Dr. Magil was a Sr. Research Scientist in the formulation department working on new analytical methods supporting formulation development for several protein and peptide products. She also worked at Bion, Inc, and the Howard Hughes Medical Institute and the Massachusetts General Hospital providing direction to the core laboratory serving investigators at three institutions.
Dr. Magil holds a Bachelor’s degree in Chemistry from Carnegie-Mellon University and a Ph.D. in Biochemistry from the University of Minnesota Medical School.