Expertise: Method  development, qualification, validation, transfer and life-cycle  management for peptides and protein therapeutics.  Experience with  contract organizations and overseeing contractors.  Creation,  implementation, and management of reference standards for a  biopharmaceutical.  Design quality and managing interfaces for a random  access immunoanalyzer.  Realizing practical solutions.

Experience: Headed  diagnostic and QC groups at Abbott Laboratories and PPD.  Headed QC  validation at Genzyme responsible for method development, qualification,  validation, transfer, and life cycle management.  Owned quality systems  as part of consent decree covering methods and instrument  qualifications.

Other:  CASSS  Associate Director, member of CASSS North American CMC Forum organizing  committee and co-chaired 2014 CMC Forum Effective Management of  Contract Organizations: Sponsors, Contract Organizations, Health  Authorities and Patients: Keeping the Product Pipeline Moving, Compliant  and Available.