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 electronic documentation system for Shire Quality Documentation Globally.

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 redesign of the Sampling System to meet Consent Decree commiments.

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 laboratory were met. Implementation of this program resulted in a savings of 1.5 full time equivalents. Program manager for the single source vendor equipment program (PerkinElmer OneSource). Actively managed onsite vendor personnel and scheduling of equipment preventative maintenance, qualification and repairs to ensure equipment downtime was minimized (90% of repairs completed within 24 hours, remaining 10% within 72 hours) while maintaining a high level of compliance.Aligned Laboratory Instrument Qualifications with guidance documents and customer methods in order to ensure compliance. Reviewed new guidance documents and customer methods for changes and ensure laboratory equipment validation is adjusted accordingly.Validation Manager for the implementation of Ahura Handheld Raman, a critical component of the Raw Materials group’s Lean strategy, as featured in June 2010 issue of Pharmaceutical Engineering. Developed the validation approach and authored testing documentation which allowed the implementation of software in a compliant manner.Successfully managed the validation for Spectrum 100 FT-IR and associated software in the QC Laboratory. In addition to developing validation approach and authoring testing documentation for the associated software established a strategy for a QC built reference library for raw material ID testing. Validation lead for upgrade of laboratory CDS from Agilent Cerity A.2.02 to A2.05 CDS. Served as SME for validation documentation and 21CFR Part 11 Gap Analysis.

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 time implementing new assay templates (approximately 50 hours a year) while ensuring consistency and a high level of compliance

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 processing without delays. Trained lab personnel on analytical methods including Sialic Acid analysis, Protein A, Size Exclusion, Ion Chromatography, as well as the use and care of HPLC equipment (Dionex, Agilent 1100/1200, and Waters)

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 including pump rebuilds and performed all associated qualification testing following approved methods. Responsible for training other analysts on the use and care of the Dionex instruments and working with service engineers. Trained new analysts on testing methods and GMP documentation practices.

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