Lexington, Massachusetts, United States
Formulation scientist, biochemist, and team leader with consistent record of research excellence demonstrated by peer-reviewed publications and 9 years of industrial experience Specialties: Liquid and lyophilized formulation development of parenterals Protein biochemistry, Tech transfer, Regulatory filings, Team leadership
Technical leader for the pharmaceutical development of pipeline products (biologics) Develop formulation processes for drug substance and drug product throughout their product lifecycle using Quality by Design principles Subject matter expert for biologics drug product manufacture, stability and technology transfer Author regulatory submissions to support clinical development and licensure Lead Process Development Project Team and clinical state CMC Team
Pharmaceutical development of protein products from nonclinical to clinical phase Pre-formulation and formulation development of protein drugs (liquid and lyophilized) Tech transfer for clinical manufacturing Stability and comparability studies Representing pharmaceutical development in cross-functional project teams Writing and executing protocols, summarizing of results in reports
Liquid and lyophilized formulation development of proteins, peptides and small molecule pharmaceuticals Project management and communication of results to clients with written reports and oral presentations Supervision of research associates
Expression, crystallization and structure solution of a human T cell receptor/MHC II-peptide complex related to autoimmunity. Hahn, M., Nicholson, M.J., Pyrdol, J., and Wucherpfennig, K.W., (2005) Unconventional topology of self peptide-major histocompatibility complex binding by a human autoimmune T cell receptor. Nat. Immunol., 6, 490-496.
Structure solution of Fab-fragments in complex with synthetic peptides derived from combinatorial libraries Maintenance of x-ray equipment Training of students in protein crystallography Hahn, M., Winkler, D., Welfle, H., Welfle, K., Misselwitz, R., Wessner, H., Zahn, G., Scholz, C., Seiffert, M., Schneider-Mergener, J., and Höhne, W., (2001) Crossreactive binding of a cyclic peptide to an anti-TGF alpha antibody Fab-fragment. J. Mol. Biol. 314, 293-309.