Experience: 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”.
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