Manage technology transfer and scale up for in vitro diagnostics tests and reagents for real time PCR assays in a cGMP, 510k, ISO-certified environment. Experienced with molecular assays including LAMP, NGS, and Real-Time PCR using both Taqman and Scorpion Probes, as well as with immunological assays (ELISA, IFA).Led operational team in vendor qualification for critical components leading to > $2 million per month savings for company.Led operational team in scale-up validation of Real-Time PCR product for congenital CMV diagnosis using neonatal saliva and urine.Executed international site-to-site product transfer of reagent production for five unique LAMP onco-hematology assays, including validation of new equipment and development of manufacturing and quality control SOPs.Write and execute protocols for manufacturing validations, performance/process improvements, shipping studies, and equipment performance qualifications. Analyze produce data and write reports that meet quality standards. Troubleshooting, NC investigations, and process improvements for immunological assays including ELISA and IFA and molecular assays including LAMP and Real-Time PCR.

Manage technology transfer and scale up for in vitro diagnostics tests and reagents for real time PCR assays in a cGMP, 510k, ISO-certified environment. Experienced with molecular assays including LAMP, NGS, and Real-Time PCR using both Taqman and Scorpion Probes, as well as with immunological assays (ELISA, IFA).Led operational team in vendor qualification for critical components leading to > $2 million per month savings for company.Led operational team in scale-up validation of Real-Time PCR product for congenital CMV diagnosis using neonatal saliva and urine.Executed international site-to-site product transfer of reagent production for five unique LAMP onco-hematology assays, including validation of new equipment and development of manufacturing and quality control SOPs.Write and execute protocols for manufacturing validations, performance/process improvements, shipping studies, and equipment performance qualifications. Analyze produce data and write reports that meet quality standards. Troubleshooting, NC investigations, and process improvements for immunological assays including ELISA and IFA and molecular assays including LAMP and Real-Time PCR.

Manage technology transfer and scale up for in vitro diagnostics tests and reagents for real time PCR assays in a cGMP, 510k, ISO-certified environment. Experienced with molecular assays including LAMP, NGS, and Real-Time PCR using both Taqman and Scorpion Probes, as well as with immunological assays (ELISA, IFA).Write and execute protocols for manufacturing validations, performance/process improvements, shipping studies, and equipment performance qualifications. Analyze produce data and write reports that meet quality standards. Work on troubleshooting for immunological assays including ELISA and IFA and molecular assays including LAMP and Real-Time PCR.Executed international site-to-site product transfer of reagent production for five unique LAMP onco-hematology assays, including validation of new equipment and development of manufacturing and quality control SOPs.Led operational team in scale-up validation of Real-Time PCR product for congenital CMV diagnosis using neonatal saliva and urine.

I manage and run bookings for my Americana band, as well as composing and recording as a vocalist and playing guitar, mandolin, and tenor guitar.

*Spearheaded development of all reagents for carrier screening assay. Developed production SOPs and QC methods and specifications for 160 unique reagents and trained production and QC teams on methods.*Develop Bill of materials for reagents and processes.*Develop Quality Control assay protocols for reagents used in CLIA lab both for new products and for legacy products. Write SOPs for QC testing and reagent formulation and train lab operations personnel.*Design studies to determine QC criteria. Write summary reports and set criteria.*Investigate NCRs and CAPAs. Provide technical input on NCR resolution.*Write protocols and summary reports for validations, range determination studies, and real-time stability studies.*Establish procedures for reagent handling and tracking and data management. Train personnel on best practices for GDP and GLP.*Technical Transfer of new reagents and associated QC and formulation procedures in coordination with Automation, RA/QA, Supply Chain, R&D, LIMS Engineering, Biostatistics, and Operations for new product launch.

*Manage transfer of new products from R&D to Operations including developing validation protocols, collaborating on manufacturing and QC testing procedures, and writing final validation reports. Product lines worked on include MATS ELISA assay, Enterovirus/Parechovirus qPCR assay, C. difficile qPCR assay, and Norovirus qPCR assy.*Investigate complaints and isolated root cause of failure for confirmed complaints. Generate technical reports to summarize findings of investigation*Investigate production failures and isolate root cause. Develop and validate process improvements for operations procedures, including improving testing for Chlamydia IFA slides to reduce false rejections of lots and changing manufacturing and assay protocols to reduce inter-lot variability of internal controls for PCR assays.

*Represented quality control in new product validations for products. Developed and validated quality protocols and set acceptance criteria for new assays. Evaluated current criteria for molecular products and worked to continually improve testing methods and criteria to ensure maximum accuracy in evaluating product performance.*Generated NCMRs and deviations for processes and products that did not meet specifications.*Evaluated quality, stability of ELISA, IFA, Plexus/Luminex, and RT-PCR products and raw materials. Investigated non-conforming materials to determine root cause of failure. Developed processes to improve testing methodologies.*Managed Quality Control patient panel inventory, including obtaining potential samples, and managing data for samples to determine sample acceptability for inclusion in patient panels.*Managed Stability program for all molecular products, including scheduling all testing, ensuring that stability testing requirements are met, obtaining materials, and trending all data. Evaluated material eligible for extension of expiration dating. Date extension of materials resulted in a cost-savings of $50,000 for 2012.*Generated technical reports and data summaries for investigations, sera qualifications, stability/date extensions, validations, reference cut-off qualifications, retest plans, and non-conforming material reports.*Trained other QC technicians on QC lab procedures and new assay procedures.*Coordinated quality control testing with production, inventory control, and planning to ensure that all products and raw materials received are tested in a timely manner.*Wrote and revised quality control specifications and protocols.*Initiated improvement project for revising slide acceptance criteria, integrating new camera technology into quality control procedure to more accurately measure detachment.*Initiated improvement project to revise IFA control release testing procedures to save labor and materials.