Scientist
CurrentAt Nuclea we manufacture and sell ELISA and IHC immunoassay kits for commercial sale. These kits focus on oncologic biomarkers including Her2 which is FDA-cleared. While at Nuclea I contributed in multiple disciplines including serving as laboratory manager of the Cell Culture laboratory where we generated large supplies of critical antibodies and/or antigens through bioreactor production. We subsequently purified/characterized them using defined protocols for approval in use in our IHC and ELISA kits. I also have worked extensively in the Quality/Regulatory departments through active participation in our CAPA program, and as a certified internal auditor for several audits/year. These duties consisted of significant documentation and DHR checks and updates as required for our GMP compliance. I also have contributed when needed in the manufacturing and shipping departments to ensure accurate documentation and packaging to meet customer sales.