Designed and carried out Arrhenius-based aging studies to extend product shelf life (>$500k savings)Developed and implemented complex MES models in a synthetic chemistry environment (2-day average cycle time savings)Facilitated manufacturing process scale-ups to increase product yieldLeveraged proficiency with analytical HPLC, UV-Vis quantification, and thin layer chromatography to troubleshoot product nonconformancesLed the design and implementation of cross-site product… Show more Designed and carried out Arrhenius-based aging studies to extend product shelf life (>$500k savings)Developed and implemented complex MES models in a synthetic chemistry environment (2-day average cycle time savings)Facilitated manufacturing process scale-ups to increase product yieldLeveraged proficiency with analytical HPLC, UV-Vis quantification, and thin layer chromatography to troubleshoot product nonconformancesLed the design and implementation of cross-site product transfers to facilitate positive impacts on Cost of Goods Sold Show less

Serving as supervisor of Incoming Quality Control activities. Responsibilities include development of material testing parameters, database development, technical nonconformance evaluations, and people management.

Serving as a process engineer for the Incoming Quality Control and Device History Review groups utilizing a wide array of process improvement techniques.Project Manager and implementer of a number of cost avoidance initiatives resulting in an estimated $210,000 savings per year.Developed and validated automated programming interfaces (APIs) to improve data analytics and limit manual processing of data utilizing SAP and Quick Base.

Served as the Software Validation Project Manager and software validation SME for the Pleasanton site aligning all of the manufacturing groups to ISO:13485 and 21 CFR Part 11 complianceAutomated programs using VBA to track quality metrics, linking TrackWise and Agile data with Microsoft Excel and Outlook resulting in a time savings of 788 hours per yearChange Control Validation and Review Board Lead responsible for scheduling topics for change and mediating the discussions for required… Show more Served as the Software Validation Project Manager and software validation SME for the Pleasanton site aligning all of the manufacturing groups to ISO:13485 and 21 CFR Part 11 complianceAutomated programs using VBA to track quality metrics, linking TrackWise and Agile data with Microsoft Excel and Outlook resulting in a time savings of 788 hours per yearChange Control Validation and Review Board Lead responsible for scheduling topics for change and mediating the discussions for required action items and appropriate follow-upsServed as Site Quality Lead for Complaints in fielding and performing the initial investigations for product complaints at the Pleasanton site as well as product holds, recalls, and customer notifications Show less

Network Raw Materials Single Point of Contact releasing half of all materials in 2016Managed and compiled raw material metrics bringing awareness to “Right First Time” Class A practices and facilitated discussions that subsequently raised site adherence from 63% to 95%Saved Genentech, Inc. an estimated $2 million annually through vendor shipment consolidationsPrevented clinical and manufacturing site raw material stock-outs through rush release accommodationsOptimized QA release… Show more Network Raw Materials Single Point of Contact releasing half of all materials in 2016Managed and compiled raw material metrics bringing awareness to “Right First Time” Class A practices and facilitated discussions that subsequently raised site adherence from 63% to 95%Saved Genentech, Inc. an estimated $2 million annually through vendor shipment consolidationsPrevented clinical and manufacturing site raw material stock-outs through rush release accommodationsOptimized QA release SOPs to remove one full-time equivalent’s worth of work by implementing a Single Signature Review and Release strategyTrained employees on reconciliation between manufacturing and enterprise consumption systems Show less

Created a new Corrective and Preventive Action database to provide a seamless query interfaceCoded advanced Excel macros for capacity metrics cutting query time by 2 hours/weekCo-creator of Vacaville Quality Systems website in compliance with Roche gSite specifications

Developed novel approach to facilitate bacterial Ampicillin resistance through reverse genetic engineeringEmployed ChIP Sequencing using antibodies to bind with Drosophila DNA to study genetic variancePiloted new research into genetic perturbations on Drosophila progeny linking starvation and gene expression quantified through Ion-Exchange Chromatography

Performed data analysis of Genentech Review and Release Process to determine gaps and optimize procedures which estimated to save 10% of allocated time and resourcesEmployed skills in SAP, Excel, and MiniTab to evaluate Goods Release Processing TimesSaved Genentech, Inc. an estimated $500,000 in 2014 through suggested Good Release Targets for chemical materials