- Develop reagents and assays for formulation and potency assays to support vaccine development and commercialization.- Working in conjunction with other staff write and get approved VICH compliant protocols for assay validation.- Produce reagents for anticipated transferring of assays into the QC laboratory.- Provide technical guidance to junior staff.- Troubleshoot problematic assays when required.- Manage a team of analytical scientists.

 Drove the development of the biochemical aspects of a new immunoassay platform. This included: - Developing antibody based reagents for immunoassays. Including optimization of the conjugation, antibody pairings, and the incubation conditions. - Working extensively in collaboration with engineers and scientists of widely varied backgrounds in a mutually supportive way to develop a new immunoassay platform. - Staying familiar with current trends in medical diagnostics throughout the world. - Extensive liaising with suppliers of biochemical reagents and scientists from partner companies. Worked as part of a team that developed and commercialized an amperometric lactate sensor and an amperometric creatinine sensor. This included: - Assisting in the compilation of the 510K submission(s). Specifically drafting CLSI compliant protocols for interference testing, compiling the data and writing the interference testing portions of the 510k submissions and product literature. This also involved tweaking sensor formulations to reduce unacceptable interferences. - Developing stable reagent inks and semi-permeable diffusion membranes for the sensor. - Writing production documentation, training production staff and coordinating the transfer of the 'print mix' preparation to the production staff. - Significant amounts of troubleshooting to make the sensor functional. Specifically hundreds of rounds of forming hypotheses, testing the hypotheses, analyzing the data and repeating. As a solo project in response to significant product recall I developed and implemented quality control measures for the enzymes used in the amperometric sensors. This included: - Communicating with Epocal’s enzyme suppliers to garner an understanding of their quality control methodologies and to bring them in-house. - Validation of the procedures for in-house use. - Training junior and production staff on the methods being used.

- I was the primary scientist responsible for the antibody-enzyme conjugates used in the i-stat immuno cartidge.- I have completed formal Abbott trainings in GLP/GMP, Design Control, Process Validation and Metrological Traceability.- As part of the bioreagent team I place in significant role in setting up a production capable lab.- Work in the development and implementation of antibody-enzyme conjugate related process and test method validations.- I have done extensive analytical and preparatory size-exclusion chromatography, including implementing the use of HPLC as a validated production tool and extensive size-exclusion FPLC purifications.- Work on the qualification of production biochemical reagents.- Design and implement strategies for equipment qualification (HPLC, ELISA Plate Reader, ELISA Plate Washer, MilliQ system, FPLC System).- Perform data analysis and compilation.- Work on long-term projects to make the antibody-enzyme conjugation procedures more robust, repeatable, validation-friendly and cheaper.- As part of the bioreagent team I was involved in executing and implementing the necessary responses to bioreagent related quality audits.- Production of antibody-enzyme conjugates as needed.

- Working under minimal supervision I develop and troubleshoot novel immunoassays for future diagnostic use. - I have done substantial amounts of independent development of immunoassays in 96-well microtitre plate format, from initial antibody pairing studies to final performance characteristics for both established and novel markers (both ELISA and fluoroimmunoassay)- I have spent large amounts of time as part of a team on the development of an immunoassay on a central lab style diagnostic machine (Vitros ECi)- Work as part of a team with a partner company in the development of a POC platform/test (specifically development and testing of Ab-label conjugates)- Small-scale mono and polyclonal antibody purification and testing for own use in early stage immunoassay development.- Develop and optimize protocols for conjugating antibodies to enzymatic labels, biotin, fluorescent dextrans, fluorescent microspheres, and other fluorescent labels.- Perform data analysis and compilation.- Perform extensive literature searches on the science and technology being used and developed in order to troubleshoot unique problems.- Contact and function as a liaison with other companies that are associated/involved with the project regarding the scientific aspects of the work being done- Work independently on keeping projects moving forward with a focus on eventual commercialization- HPLC analysis of purified antibody/conjugates- Hybridoma culture, ascites production and other basic cell culture required for early stage immunoassay development.- DNA extractions/PCR- FPLC purification- SDS-PAGE/Western blotting- Small animal handling.