William C. Schinzer, PhD
Bill Schinzer has worked for more than 30 years within the pharmaceutical industry and has been an independent consultant since 2010. He worked for Upjohn/Pharmacia/Pfizer for 23 years and then worked for 4 years at an analytical CRO before starting his consulting business. During his career he has developed and validated analytical and physical methods, served as an analytical team leader, managed drug development projects, and directed the work of a method development group.
Bill has significant experience with API development (pilot plant IPC, intermediate, and API methods and specifications) and as well extensive experience with drug product development. He has worked to understand and control solid oral dosage forms including controlled release tablets and capsules; semisolid dosage forms (Franz cell methods); and sterile injectable formulations. He has also worked with diagnostics and with combination medical devices including pumps and drug coated stents.
Bill has extensive experience with chromatographic methods, titrations of various sorts including KF for moisture, thermal methods of analysis (DSC and TGA), and dynamic moisture sorption. He has a significant interest in salt/polymorph screening and selection, and resolving problems with this issue. Sourcing and characterization of reference standards is also an area of particular interest for Bill. Outside the lab, he leverages his big pharma/CRO experience to help clients identify and engage CRO labs and CRMs appropriate to their needs. Bill has generated protocols and reports for method transfer or validation; specifications for raw materials, intermediates, APIs, and drug products; and regulatory CMC filings including INDs and NDAs.
Prior to beginning his career in the pharmaceutical industry, Bill earned a BS in Chemistry from Eastern Illinois University and a Ph.D. in Physical Chemistry from Indiana University, Bloomington.
Bill has significant experience with API development (pilot plant IPC, intermediate, and API methods and specifications) and as well extensive experience with drug product development. He has worked to understand and control solid oral dosage forms including controlled release tablets and capsules; semisolid dosage forms (Franz cell methods); and sterile injectable formulations. He has also worked with diagnostics and with combination medical devices including pumps and drug coated stents.
Bill has extensive experience with chromatographic methods, titrations of various sorts including KF for moisture, thermal methods of analysis (DSC and TGA), and dynamic moisture sorption. He has a significant interest in salt/polymorph screening and selection, and resolving problems with this issue. Sourcing and characterization of reference standards is also an area of particular interest for Bill. Outside the lab, he leverages his big pharma/CRO experience to help clients identify and engage CRO labs and CRMs appropriate to their needs. Bill has generated protocols and reports for method transfer or validation; specifications for raw materials, intermediates, APIs, and drug products; and regulatory CMC filings including INDs and NDAs.
Prior to beginning his career in the pharmaceutical industry, Bill earned a BS in Chemistry from Eastern Illinois University and a Ph.D. in Physical Chemistry from Indiana University, Bloomington.