At 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.

At ALPCO, we design and sell immuonoassay kits (ELISA/RIA) in addition to antibodies and recombinant proteins to the life science and medical diagnostic industries. Our emphasis is on immunoassays in areas of research that include diabetes, obesity, and metabolic syndrome, in addition to oncology. Our customers include the following: clinical and hospital reference labs, biotechnology and pharmaceutical R&D labs and basic academic research labs. I collaborate with cross-functional colleagues and am responsible for the development and implementation of new products and improvements to selected existing products and processes to ensure well-defined, robust,scalable, and economical methods. I am also establishing and supporting analytical programs for raw material and kit components to ensure they are appropriately characterized. I evaluate our products and assist with the effective inter-departmental knowledge transfer from R&D to manufacturing. I author novel protocol drafts, which typically include parameter testing across multiple disciplines, particularly during the transfer of analytical and QC release parameters, and products from development and manufacturing. I am also an active member in our quality system through participation in our internal audit program.