Michael James

Experience

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  Robert Wood Johnson University Hospital

  Jun 1991 - Feb 2001

  Clinical Services Technician

  January, 2013 Renewed PTCB certification (Pharmacy Technician Certification Board)up to 2001 PTCB certification (Pharmacy Technician Certification Board)1991 Phlebotomy Certification (Adult/Pediatric)RELEVANT COMPUTER SOFTWARE SKILLS:• Microsoft Office package (Outlook, Word, Excel, Power Point, with limited use of Access) Responsible for aseptic preparation of sterile intravenous admixtures, peritoneal dialysis solutions and pediatric oral solutions. Unit dose preparations from bulk medication supplies for PYXIS pharmacy med system. Practice drug dosage calculations and drug delivery under a supervising pharmacist. Specialize in pediatric care and support involving investigational drug studies. Show less

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  Huntingdon Life Sciences

  Jun 1998 - Jan 2013

  RELEVANT PROFESSIONAL COURSES:June, 2011 Waters ACQUITY Systems Maintenance and Operation TrainingApril, 2010 API 4000-5000 Maintenance and Service w/ ANALYST software Applied Biosystems, Framingham MassachusettsAugust 2004-Current Radiation Safety TrainingApril 17-19, 2001 API 3000 “Q” Operator Training w/ ANALYST software Applied Biosystems, Framingham Massachusetts1998 Certified to work with radio-labeled samples and reference standardsRELEVANT COMPUTER SOFTWARE SKILLS:• Microsoft Office package (Outlook, Word, Excel, Power Point, with some use of Access) • Analyst (AB Sciex software)• Total Chrom (HPLC software)• Waters Corp. MassLynx software• SoftMaxPro (Molecular Devices Corp. software for plate readers)• Implemented changeover from MassChrom to Analyst 1.2 software for AB Sciex Mass Spectrometers (and eventual upgrade to version 1.4.2)1. Perform and document scheduled maintenance and calibration activities for equipment and instrumentation across the BAS division. Maintain/review records for consistency with required documentation practices. 2. Perform (or schedule and supervise service contractor) and document non-routine maintenance or calibration activities for equipment and instrumentation across the BAS division. Maintain/review records for consistency with required documentation practices. Ensure archival of documentation, as necessary.3. Perform IQ/OQ of new equipment to be used across the BAS division as well as inclusive of the team assigned to perform any software validation for new equipment. 4. Maintain log of all equipment across the BAS division with indication of equipment status. 5. Provide management with periodic reports on the status of equipment readiness along with resource needs and roadblocks.6. Order, inventory, maintain use/sign out records and store supplies required for BAS department.7. Compile metrics for the System Specialist group. Show less 1. Optimizes and operates various platform mass spectrometers (AB Sciex models 3000, 4000, 5000 and 5500) and LC instruments (Waters ACQUITY, HTC PAL autosamplers, Agilent 1100 & 1200 series pumps)..2. Organizes the department schedule, ensuring that the samples are injected and data are acquired according to the required standards and internal SOPs.3. Successfully performs non-routine maintenance of LC instruments and MS components. 4. Troubleshoots and calibrates analytical instruments. 5. Performs preventive maintenance of some MS components.6. Participates in method development and validation, must be able to employ and troubleshoot the methods using Cohesive systems (turbulent flow chromatography).7. Supervises IQ, OQ, PQ of analytical instruments.8. Integrates various aspects of method development to assist in providing robust methods. 9. Trains others on mass spectrometric techniques (incl. operation, troubleshooting, routine and non-routine maintenance).10. Must be organized and have good and effective interactions with team members and other departments.11. Schedules the daily use of instruments; provides monthly reports; ensures that instruments are calibrated on time.12. Demonstrates ability to communicate and have a technical input on mass spectrometric issues internally and externally.13. Writes and revises SOPs related to LC/MS instruments, software and procedures. Show less Reporting to and under supervision of the Director, Bioanalytical Services, a Research Scientist (Senior Research Scientist) is responsible for feasibility tests and R&D activities using a variety of wet chemistry techniques, operating of analytical instruments and its related software, writing reports. All in accordance with SOPs and GLP guidelines. Research Scientist (Senior Research Scientist) supervises the group of Scientists/Analysts in the laboratory and computer related work.Performs all duties required of to maintain the flow and progress of the current project. Assists the project manager in scheduling of the project and maintains the quality assurance of the data in a GLP environment. Operates and maintains instruments for LC/MS assays (AB Sciex API 365, 3000 and 4000). Coordinates the scheduling of analytical batches and performs the injection and data collection of the batches for the project. Troubleshooting, optimization and routine maintenance of the instrument are required skills. Knowledge and use of the following software applications: Microsoft Word and Excel, Watson, Macintosh Mass Chrom, and Analyst. Research and method development and optimization of chromatographic conditions are required skills for incoming projects. Show less

  • Systems Specialist -Analytical Services Division

    Nov 2011 - Jan 2013

  • Supervisor, LC/MS

    Oct 2002 - Nov 2011

  • Senior Scientist / LC-MS/MS Operator

    Jun 1998 - Oct 2002
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  Robert Wood Johnson University Hospital

  Mar 2013 - Nov 2015

  Certified Pharmacy Technician-Per Diem
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  Eurofins/Product Safety Labs

  Apr 2013 - May 2019

  Senior Analytical Chemist

  Set-up and conduct experiments in accordance with Protocol, SOP’s and GLP standards.• Perform method development and validation in support of study design. As the lead user of Sciex LC/MS-MS system, 15+ methods annually have been fully validated and implemented for use with study samples with minimal supervision.Assists the Study Director with all phases of study design, scheduling and conduct and acts proactively to identify problems and potential problems.• Research historic methods, purchase standards and reagents, analytical columns, in order to reduce time and materials cost for each project (approximately 10-15% cost savings per project during time of employment Methodically maintain precise records of all experiments in accordance with good laboratory practices inclusive of GLP controlled forms and with method development lab notebooks.Assists in writing, reviewing and editing data (both self and peer review), reports, protocols and SOP’s in conjunction with QA.• Operates, maintains, calibrates and repairs all chromatographic equipment (Sciex API4000 MS, Agilent QTOF 6540, Agilent 7500i ICP-MS, Thermo AA, Agilent & Thermo HPLC, Agilent LC 1100, 1220, 1290 series, GC 6890, GC/MS and UltraWave microwave digester)) required for study conduct, this provided less down time for each analytical system.Performs routine troubleshooting and maintenance on analytical instruments. Places orders for standards, solvents and general lab materials as needed. Washes glassware as needed and maintains a clean working environment for all team members. Show less

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  Aurolife Pharma USA

  Jul 2019 - Oct 2019

  Analytical QC Chemist
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  International Flavors & Fragrances

  Jan 2020 - Aug 2021

  Flavors QC Chemist
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  International Flavors & Fragrances

  May 2024 - now

  Product Integrity Analysis Chemist III