Independent consultant

Major strengths include:
• Assay Development – ELISA and magnetic beads-based immunoassays for manual and
automated assays on TECAN
• Antibody development, production, purification, qualification and commercialization
• Cell culture – suspension and adherent cultures for antibody and biomarker production
• Chromatography – affinity, ion-exchange, and size exclusion

Immunoassay development: ELISA and Ultrasensitive Cytokine Detection Assays using Singulex Erenna technology. Performed biomarker assay development and transfer of Laboratory Developed Tests to Singulex Clinical Laboratory. Performed troubleshooting and process improvement activities for TECAN automated assays.

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Managed the Rare Reagent group; a team of research associates, for new product development, maintaining sales, and delivering autoimmune, complement, and bone biomarker reagents to inventory and internal manufacturing. Served as an Internal Auditor and on the CAPA team for quality improvements. Managed complaint testing and investigations for reagents. Managed creation of budgets, capital expenses, acquisition of equipment and IQ/OQ/PQ validations.

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• Performed antibody production, purifications, testing (SDS-PAGE, ELISA, and Isotyping), antibody conjugations and conjugate characterization.
• Designed facility space for R&D lab, Cell Culture labs, Vivarium, and Cold Room for facility move from Mountain View to Santa Clara.
• Interacted with suppliers to ensure specifications were met for raw materials and custom orders.

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Performed antibody production, purification, conjugations, and qualification testing (SDS-PAGE, Western Blots, ELISA, and Isotyping). Managed cell culture work for Northern CA operations.

Promoted from Process Group Chemist III

• Transferred Autoimmune and Complement (AI&C) product line from San Diego to the Northern CA facility. Converted documentation to Quality System used in Northern CA.
• Manufactured ELISA kits, and purified antibodies in a GMP/GLP environment. Managed research reagent inventories including production, testing, and tracking for Monoclonal Antibodies, Complement Proteins, Antisera, and Human Depleted Sera products.

Managed lab maintenance, organization, and lab technicians. Scheduled and coordinated research studies. Performed cellular studies including Flow Cytometry, Proliferation Assay, Cytokine ELISA and ELI Spots.