Emil George

Experience

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  Celgene

  Jun 2007 - Mar 2017

  Sr. Metrologist/Validation Specialist

  • Initiated IOPQ for installation of Empower 3.• Initiated, executed, and reviewed new equipment qualification documents (URS/DQ, IQ, OQ, PQ) as well as perform equipment qualifications of FTIR, UV/VIS, walk-in and reach-in chambers.• Executed mapping and qualification of walk-in and reach-in chambers using Kaye ValProbe Wireless Data Logger System.• Performed risk/impact assessments for new equipment qualifications and deviations.• Executed change control documents for qualified equipment and controlled temperature environments.• Maintained and updated Metrology Department SOPs.• Coordinated outside vendor visits for equipment calibration and maintenance activities and assisted department management with new equipment evaluation or purchase.• Coordinated with internal departments (Formulation, Analytical, QC, Engineering, etc..) all validation activities and provided customer support.• Performed routine calibration of laboratory equipments and facility systems and ensure maintenance by Blue Mountain Calibration Manager database.• Performed routine Internal Audits.• Assisted with troubleshooting in the facilities, utilities, critical systems, equipment, or instrument in the manufacturing packaging and laboratories areas.• Reported and initiated calibration OOT deviations following site policies and completed investigations associated with deviation investigations.• Oversaw metrology laboratory operations and inventory system Show less

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  Abraxis BioScience

  Jun 2007 - Oct 2012

  Scientist

  •Successfully validated analytical test methods for equivalency between USA and Japan for Abraxane submission. •Developed and designed protein assay test method using Size Exclusion Chromatography for lyophilized finished product. •Developed KF procedure to improve efficiency and accuracy of the current procedure for water determination in Raw Materials and Finished Product. •Performed analytical testing for the stability and formulation groups using HPLC, GC, ICP, KF, FTIR and UV/VIS. •Designed, validated and executed experiments for approved study protocols, test methods, and technical reports while maintaining ICH and cGMP regulatory compliance. •Responsible for creating supporting documents for IND submissions.•Responsible for method development, execution of validation protocols, stability testing, and formulation support – HPLC, GC, IC, ICP and various wet chemistry methods (Karl Fischer, pH, Osmolality, PSA, etc…)•Initiated deviation reports and CAPA.•Supported and maintained 21 CFR part 11 compliant BMS such as Stability Database Software (Micro Control Solution), Quality Management Solution (TrackWise), Business Management Software Solution (SAP), Learning Management System (LMS), Documentum, Chemstation/Chemstore and Empower Show less

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  CoreRx, Inc.

  Apr 2017 - Jun 2017

  Chemist III

  • Design and execute experiments for IND, ANDA submissions for approved test methods, and SOPs while maintaining ICH and cGMP regulatory compliance. • Responsible for creating supporting documents for IND submissions.• Responsible for method development, execution of validation protocols, stability testing, and formulation support – HPLC, Karl Fischer, pH, PSA, Viscosity, etc…)

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  Bausch Health Companies Inc.

  Feb 2018 - Mar 2019

  Quality Compliance/ Tech Transfer

  • Coordinated all necessary Nasal Products functions: Instruments Operational SOPs, method transfer protocols, test methods, handling of materials management while maintaining ICH and cGMP regulatory compliance. • Worked closely with Regulatory/CMC regarding submitting PAS for new nasal Specifications.• Prepared proposed FP Specifications for new Nasal tests for submission to FDA.• Reviewed & approved of Nasal SOP’s, FP specifications, test methods and method transfer protocols by contract labs.• Coordinate routine meetings & facilitate communications with RA, R&D, QC, Stability, material management and other groups for successful analytical methods & materials transfer.• Responsible for scheduling of repairs and calibration of all nasal products instruments.• Review and approve IOPQ protocols for new spray nasal products instruments.• Assisted in risk/GAP assessment for new equipment qualification. Show less

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  Catalent Pharma Solutions

  May 2019 - Oct 2020

  Scientist

  • Performed analytical testing on softgels stability and formulation support using HPLC, GC, KF, Dissolution and UV/VIS.• Validated and executed Dissolution validation for approved study protocols, test methods, and technical reports while maintaining ICH and cGMP regulatory compliance.• Initiated & reviewed of assigned project SOP’s, test methods and method transfer protocols by contract labs.• Participated in internal audit of QC & AR&D labs for safety and compliance

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  BL Bio Lab - Dietary supplement

  Dec 2020 - Oct 2021

  Quality & Validation consultant, Logos Consulting LLC

  • Qualification of Environmental Chamber, Agilent HPLC 1200 and Densitometer.• Coordination of laboratory control system, quality management system, equipment and materials system.• Implemented new processes on employee training program, documentation control, discrepancies and failure investigations, equipment, analytical testing on raw materials and finished products.• Implemented department SOP’s, test methods, and protocols.• Performed IQOQPQ of various instruments such as FTIR, Densitometer, balances and pH meters Show less

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  Escalate Sciences - American Injectables

  Oct 2021 - Oct 2023

  Sr Validation Engineer

  • Performed PQ of Warehouse Mapping for Temperature and Humidity per USP guidelines.• CSV of OpenLab CDS, Theromo OMNIC, SCADA, and test scripts of Madgetch 4 Secure software. • Assisted in Environmental Monitoring PQ of Cleanrooms (viable air, viable surface and non-viable particulates), static and dynamic conditions. • Successfully executed the commissioning of HVAC system & c-GMP Aseptic Facility.• Assisted in executing PQ of large volume Fedegari Autoclave for process optimization. • Performed IQOQ of BOSCH Vial Filler and Filler RABS for room classification ISO 5 and ISO 6.• Executed Risk Assessment analysis on all qualified systems. • Generated and executed Validation plan, URS, Traceability Matrix for various systems.• Performed IQOQPQ of MadgeTech data loggers, incubators, and stability chambers.• Qualified QC Laboratories instruments such as Agilent HPLCs with OpenLab CDS, Nicolet iS5 FTIR OMNIC, and Analytical balances.• Trained all applicable personnel on validation protocols, SOPs for laboratory systems, FTIR, Densitometer, and HPLCs. Show less