Tim Butterfield

Background

About Tim Butterfield

Extensive experience in pharmaceutical quality, with over 20 years working in GMP and GLP quality assurance and control. Quality management of drug substance and drug product from clinical through commercial development while working with multiple cross-functional teams. Managing analytical GMP work both internally and externally with CMOs and CTOs. Author, revise, and review SOPs, specifications, analytical methods, method validations/qualifications, method transfers, stability protocols, investigations, deviations, CAPAs, and batch records. Stability management per ICH guidelines, including establishing the stability program, study design, protocol/report authoring, and execution. Author and review CMC sections for IND/IMPD and NDA regulatory submissions. Analytical techniques, including HPLC, LCMS, KF, GC, dissolution, FTIR, ELISA, SDS-PAGE, IEF, CE, Western blot, Bradford, UV/Vis spectrophotometry, bacterial endotoxin, pH, osmolality, appearance, and cell-based methods.