Riley Reyes Email and Phone Number

NovaSeq X Reagent Cartridge:-Supported NPI launch of NovaSeq X Reagent Cartridge consumable.-Supported scale up of manufacturing from pilot to production scale. -Helped author and review requirements and functional specs for development of IOPQ protocols. -Executed system validation protocols (IOPQ).-Led efforts to implement and validate integration of production systems with custom SCADA.-Led development MES Workflow for production, enabling electronic data collection, real-time process control, and integration with SCADA.-Served as Product owner in scrum development of several SCADA applications to automate process data collection and implement engineering control over operator electronic transactions.-Setup DEV SQL databases to facilitate integration testing with production systems without risk to production data and configurations.-Led creation of GitHub repositories and configuration of Teamcity to implement build control over production recipes and critical system files. -Led root cause investigation of leading scrap cause and collaborated with reliability engineers and maintenance teams to implement fixes to realize $490,000 in scrap avoidance.-Co-authored pFMEA to document risk, likelihood, and severities to ensure sufficient process control.-Created JIRA ticketing system with cause and insight codes to track live production issues and ensure timely escalation and resolutions.-Created process dashboard to display and trend data for production issues sourced from JIRA.

On assignment from Randstad Life Sciences: April 2019 - April 2020FTE: April 2020 - November 2020-Participated in downstream operations over approximately 60 production runs for two different pharmaceutical drugs (clinical and commercial) in a cGMP environment-Operated for column chromatography, ultrafiltration by tangential flow filtration, buffer and solution preparation, and homogenization/centrifugation operations, as well as CIPs-Interfaced with automation, validation, MSAT, facilities, instrumentation, and quality throughout operations to ensure schedule adherence and address operational challenges -Supported automation recipe testing and verified proper function of prompts-Assisted validation protocol for validating system cleanings and clean hold times -Collaborated in revising electronic batch records for buffer and solution preparation and tested the performance of those revisions in dry runs-Developed proficiency in LIMS, PI Processbook, SCADA, Oracle MES, and Oracle EBS systems as well as 5S and H&OP concepts to facilitate production and ensure compliance-Document review team member responsible for logbook reviews in production suites-Calculated production yields and performed electronic data reviews to confirm operating ranges for production runs-Initiated and wrote deviations/PRs for on-the-floor incidents in support of CAPAs