NuGEN Technologies, Inc. (NuGEN), a in vitro diagnostics company, has appointed Erwin V. Estigarribia to serve the company as vice president of operations. He reports to Elizabeth Hutt, chief executive officer of the company. Estigarribia will lead manufacturing and quality initiatives, and direct the company in achieving cGMP compliance by the end of 2009. Estigarribia was most recently senior director, manufacturing sciences with the Geron Corporation.
His responsibilities included supervision of a pilot plant facility, a drug delivery device laboratory, and a core cell culture facility. Prior to Geron, he was associate director, process development for Novartis Vaccines and Diagnostics (formerly Chiron), during which he supervised both cGMP- and ISO 13485-compliant manufacturing processes. Before Novartis, Estigarribia held a bioprocess consulting engineering position with PoroCrit and Sims SFE llc, as well as with Commonwealth Serum Laboratories (CSL, Ltd.).
Estigarribia received a bachelor of chemical and bioprocess engineering with honors from Swinburne University of Technology, Melbourne, Australia.
“Erwin’s experience in manufacturing sciences and product development in cGMP-compliant environments with novel processes makes him uniquely qualified to lead our regulatory initiatives,” noted Hutt. “NuGEN successfully earned its ISO 13485:2003 certification one year ago and is now working towards cGMP compliance. Together, these two qualifications will make NuGEN the partner of choice for pharmaceutical and biotechnology companies developing diagnostic assays, as well as for CLIA laboratories requiring rigorous quality standards.”