Monica Puskas

•13 years experience providing analytical and process support for the development of new R&D products. •1st shift supervisor of analytical laboratory supporting all R&D activities. •Leader of investigations of OOS and unexpected results. •Developed and validated analytical methods for determination of protein purity by HPLC and electrophoresis. •Transferred test methods between laboratories both internally and externally. •Worked on cross-functional R&D project teams to provide analytical test support and prioritization of lab resources. •Project Team Leader of a cross-functional team to assess feasibility of new R&D project. •Authored internal reports for characterization and comparability of manufacturing processes. •Authored and reviewed test protocols and procedures for characterization and analytical test methods. •Process development, optimization and scale-up (g-kg), including protein/peptide conjugation, enzymatic transformation, column purification and UF/DF unit operations. Technical transfer and monitoring of GMP manufacturing of API at external contract site including review of batch records. •Experience working on development of biologics and recombinant protein therapeutics. •Experience in FDA regulated environment and followed GMP and ICH guidelines.