Robert Bent Email & Phone Number

Responsible for the Shire Technical Operation Quality Manual and Global Quality Standards program. Responsible for the roll out of the Shire Global Quality Standards to Shire and acquired companies. Oversight of the Technical Operations Regulatory Intelligence program

Responsible for the oversight of Shires Global Quality Standards program Implementation and revision of Quality Standards including gap remediation and planning.Responsible for oversight of the Quality Documentation System Manage Quality Documentation staff at multiple locations Documentation process owner responsible for the implementation of an.

Responsible for the creation and implementation of Global Quality Standards for Shire Technical Operations. Forty Seven (47) Standards developed to encompass GMP/GDP regulatory and industry best practice for markets in which Shire operates.

Allston/Cambridge

Responsible for Leading Genzyme Laboratory Consent Decree projects including Stability, Quality Planning and Objective SettingSuccessfully led implementation of redesigned of the Laboratory Investigations system as part of the Genzyme consent decree and achieved Final Consent Decree Verification for the Laboratory Investigations SystemParticipated in a.

Responsible for Genzyme Laboratory Consent Decree projects including Lab Investigations, Sampling, and Laboratory Controls.Served as Interim Lead for CDMO Consent Decree activities.

Responsible for Validation/Qualification of QC Laboratory Equipment and Computer Systems at Lonza Portsmouth NH (300 instruments) and Lonza Hopkinton MA (120 Instruments). FDA, EMA, and customer audit Subject Matter Expert for analytical instrument qualification and computer systems validation for the QC Laboratory

Technical lead for project establishing a single source vendor for equipment maintenance, qualification and repair in the QC Laboratory. Developed a visual comparison matrix which allowed the comparison of three potential vendors; used for efficient selection of vendor with maximum technical and quality capabilities to ensure the requirements of the.

Responsible for several Instruments/Software validation projects in the QC Laboratory including: cIEF, Sievers TOC 900, ABI Microseq, Agilent 1200 HPLC, and GS-800 Densitometer with Quantity One Software. Developed and instituted a standard test script for the validation of assay templates on Softmax software. The standard script allowed the lab to save.

Conducted analytical laboratory investigations for out of specification results, including orthogonal testing, statistical analysis, identification of root cause, and investigation close-out. Coordinator for testing of in-process manufacturing samples; managed the workflow and work load of analysts to ensure all testing was completed to allow for forward.

Lead Analyst for method transfers (Cation Exchange HPLC and SDS-Page Analysis) from customer site to Lonza. In charge of authoring methods, qualification protocols, reports, assay executions and equipment setup. Dionex LC and IC (Conductivity, Electrochemical, and UV) technical expert; performed routine and emergency maintenance on the Dionex instruments.

Performed testing in a GMP environment including TOC analysis, pH, conductivity, A280, SDS-PAGE, glucose, and glutamine testing.