Jeffrey Staecker, PhD.

Principal Consultant

BioPhia Consulting

Jeff obtained his Ph.D. from McArdle Lab for Cancer Research in 1987 followed by post-doctoral studies in protein biochemistry at the Howard Hughes Medical Institute at Vanderbilt University. He started at Abbott Diagnostic in R & D before moving to QC management while establishing the first GMP analytical biochemistry QC group. QC responsibilities eventually extended to include a group of 75 people responsible for 250 products. While still at Abbott Jeff moved to DNA Probes where he was responsible for manufacture, testing, technical support, and customer complaints. Jeff also worked in the immunodiagnostic area at Beckman-Coulter where his roles included leading risk assessments, developmental QA, product transfers, and leading a team to put a critical product back on the market after withdrawal due to poor analytical sensitivity.

He entered the biopharmaceutical industry more than 10 years ago, initially managing a group a group at PPD that had approximately 40 clients ranging from small “virtual” companies to large biopharmaceutical companies with group responsibilities ranging from method development, method validation, method transfer, stability studies and QC release for commercial products. While still part of PPD Jeff became site head for the Wayne, PA site responsible for all aspects of operations. He moved to Genzyme as Associate Director of Validation Support where he was responsible as part of a consent-decree for method development, method transfer, method validation, analytical lifecycle management, instrument qualification, and regulatory intelligence.

Jeff is currently a Principal Consultant at BioPhia Consulting.
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