Scientist with 25+ years of expertise in most areas of biological industrial research and production. Extensive research and development experience of 15+ years including ELISA development, DNA/RNA manipulations, virology, cell culture, hybridoma generation, screening, cloning and expansion, along with protein purification, characterization, and functional validation. Experience also includes troubleshooting and process improvement. Manufacturing experience includes oversight of RUO grade ELISA kit manufacture including all quality testing during and after component and kit manufacture processes. Responsibilities also included training and direct supervision of Co-op student technicians for nearly 10 years of kit manufacture. Quality department expertise includes generation of quality system documentation including raw material incoming inspection procedures, manufacturing and associated testing documents and equipment validation plans with subsequent reports. Experience also includes 8+ years of internal auditing at multiple organizations.
Listed skills include Biotechnology, Elisa, Cell Culture, Assay Development, and 19 others.