Analytical Support

Analytics – Manufacturing- Formulations - QC

Pharmaceuticals Biotech Medical Devices Vaccines

Great experience in method development, method transfers, and validations as well as documentation, such as proficient composition of standard protocols and procedures with constant adherence to Code of Federal regulations through GMP and GLP.

Instruments - Expertise with Operation, Troubleshooting, and Maintenance

HPLC: Agilent Systems - HP 1100/ 1060 Series (Chemstation); Waters Alliance, UPLC Hclass with TUV and PDA (Empower2); PE LC (Turbochrome), TLC;

Distek Inc., Dissolution Apparatus

MS: Micromass Platform/Quattro; FINNIGAN TSQ700; Finnigan Trace; Applied Biosystems: Sciex 4000/ 3000; Advion Nanomate, HP GC/MS; MICROMASS QTOF; POLARIS Q TRAP and SIS Autoprobe, PE ICP-MS, Antek Nitrogen Detector;

Optical Spectroscopy: Convergent Biosciences iCE Analyzer with PrinCE MicroInjector, Malvern DLS, PE Atomic Absorption, Nicolet, Mettler Toledo, Kaiser FTIR/Raman, Nick-Plan Microscope (Omnic), UV Spectrophotometer- UV2101-Schimadzu; Circular Dichroism-Jasco 720; Optical Rotation Polarimeter- Jasco P1030; TOC Analyzer; Turbidimeter, Density Meter; Liquid Scintillation Counters;

NMR Bruker Avance 500 MHz, 300MHz, 400 MHz systems /ICON-NMR, XWINNMR;

Robotics: Platetrak, Minitrak, Multiprobe I and II; Apricot multi-tip dispenser; Beckman: Biomek FX;

PC: Windows 10 and MS Office 2016; SAP

Professional Experience (All Contracts)

Kaiser Optical Systems, QC Technician, Ann Arbor, MI May 2016-Jun 2016

Calibration, Performance Verification, and Inspection of newly manufactured parts and complete Raman Spectrometer to meet client manufacturing regulations.

Data management of test results of all parts.

Repair of damaged parts.

Accriva (Aerotek), Formulations Chemist, Edison, NJ Mar 2015 - May 2015

Performed formulations of coagulation indicator for medical device cartridges.

Calibration of Stago instrument, pH meter, Water filtration system, and all balances.

Call upon vendors for proper instrument function and consumable laboratory supplies.

Coordinate corrective action for technical problems related to raw materials, finished products; minimize rejects and field complaints.

Adhere to related Standard Operating Procedures (SOPs), quality system requirements, safety standards, and regulations

QC testing on Stago of formulation batches.

Ensure proper reporting and compliant documentation of lot controlled ingredients (on batch records, ERP system, etc.); provide relevant data and prepare reports as needed.

Provide advanced support for the transfer of product to routine manufacturing

Bristol Myers Squibb (Spectraforce), Lab Technician, New Brunswick, NJ Nov 2014 - Mar 2015

Managed deployment and maintenance of Process Analytical Technology (PAT), including

Individual Calibration of deployed Instrument (FTIR, Raman, Near-IR, FBRM, HPLC, ICP-MS) for in process batch preparation for clinical trials.

Interface with all vendors for Preventative Maintenance (Kaiser and Mettler)

Sanofi Pasteur Inc. (Cyberthink), Documentation Specialist, Swiftwater, PA Aug 2013 - Jan 2014

Performed equipment qualification (Antek Nitrogen Detector, UPLC Acquity, GC/MS, Turbidimeter, Density Meter, Atomic Absorption Spectrophotometer, ICP-MS, TOC Analyzer) for Manufacturing of Vaccine injectables.

Drafting URS's, DQ/IQ/OQ/PQ Protocols, Standard Operating Procedures for analytical instruments for cGMP study testing.

Submitting all documents for review and approval in company document management system

Tracked Preventative Maintenance contracts and utilized IQ/OQ/PQ Validation documentation by all associated vendors (Waters, Antek, Agilent, Perkin Elmer)

Becton Dickinson, (Lancesoft), Chemist, Franklin Lakes, NJ May 2012 - Jun 2012

AA spectroscopy and ICP-MS methods on therapeutic protein solutions in BD manufactured syringes treated in different ways with silicone oil.

Operated and Calibrated upon use DLS Zetasizer, Atomic Absorption, HPLC, and ICP-MS instrumentation for Si analysis.

Data Management using SAP.

ABC Laboratories, Staff Scientist, Columbia, MO Sept 2010 - Aug 2011

Specialist in analysis, purification, mapping, structural elucidation, and separation of proteins.

Responsible for Maintenance, Calibration, and Troubleshooting of UPLC,capillary electrophoresis, cIEF, UV/Vis spectrophotometers, FTIR, pH meter, analytical balances, pipettes, and volumetric glassware to perform analysis.

In accordance with all cGMP and cGLP regulatory requirements as defined by protocol, method, policies, and SOP’s.

oMethod transfer from clients, Development, and Validation (Forced Degradation studies, reproducibility, stability studies on therapeutic proteins.)

oMaintained vendor contracts and tracked PM dates.

oPerformed Equipment/System qualification and Wrote methods and SOP’s

Provided on the job training for new employees.

Involved in the hiring of new staff.

Pfizer Inc. (Joule), Biologist, Groton, Conn. Jun 2010 - July 2010

Ran cell based screening assay on cultured hepatic liver cells using Envision and Trilux in cGMP environment.

Merck & Co., Inc. (On Board), Biochemist II, Rahway, NJ Apr 2009 - Sept 2009

Conducted robotic high-throughput microsomal stability screening assay using (LC/MS/MS) analysis on new chemical entities in drug discovery, documented in ELN.

Operated, Maintained, Calibrated Biomek FX, Advion nanomate and Sciex LC/MS/Trap, LC/MS/Quad

Lexicon Pharmaceuticals (Aerotek), Analytical Chemist, Princeton, NJ Jan 2006 - Jun 2006

Performed early phase analytical tests using GC, GC/MS, LC, LC/MS, FTIR, UV/Vis, NIR, NMR.

Maintenance and Calibration of all instruments included calling upon vendors for troubleshooting in addition to replacing small parts in Open -Access Labs

Lohmann Therapy Systems (Aerotek), QC Chemist, Caldwell, NJ Nov 2005 - Jan 2006

QC testing following regulated procedures of OTC Transdermal Drug batches and mouthwash strips via Perkin Elmer HPLC, TLC, and Dissolution, included daily calibration of HPLC,

Perkin Elmer Life Science Instrumentation Corp., Field Service Engineer, Shelton, Ct May 2004 - Nov 2005

Serviced Liquid Scintillation Counters, and Robotic Liquid Handlers.

Primarily responsible for On Site IQ/OQ/PQ, Calibration, Preventative Maintenance calls, and troubleshooting

Novartis Pharmaceuticals Corp., Research Scientist, East Hanover, NJ Jun 2000 - May 2004

Managed optical spectroscopy lab. Carried out calibration when needed otherwise calling upon vendors to perform calibration accompanied with Preventative Maintenance visits from vendors.

Provided analytical tests for early phase drug research by utilizing:

oFTIR/Microscope, Raman, Circular Dichroism, Melting Point, optical rotation, and UV/Vis

oLC/MS and GC/MS data utilizing Xcaliber and Masslynx/Openlynx software

oOpen-access NMR instrumentation

Departmental Safety Representative- Responsible for promoting a safe and healthy work atmosphere for the analytics group by preventing occupational safety hazards.

Givaudan, GC/MS Specialist, Mt. Olive, NJ Sep 1999 – Jun 2000

Routine interpretation and identification of any nonconformance by GC and GC/MS of fragrance batches for QC.

Stepan Chemical, Quality Control Lab Chemist, Maywood, NJ May 1999 – Aug 1999

Utilized GC, GC/MS, LC/MS, FTIR, NIR, equipment, wet-chemistry techniques (Karl Fisher) for routine QC testing, also calibration of non-critical instruments such as balances and pH meters along with critical instruments also.

Additional Experience

Developed strong organizational and communication skills organizing documentation and handling office duties.

Firetronics, Administrator, Secaucus, NJ Mar 2016

United Way of NYC (Soloman Page), Program Associate, NY, NY May 2008 - Jul 2008

Dr. Fresh Inc., Administrative Assistant, Buena Park, CA April 2007 - Nov 2007

Lobster Sports, Administrative Finance Assistant, North Hollywood, CA Feb 2007- Mar 2007

Education

UMDNJ: Graduate School of Biomedical Sciences, Newark, NJ - MS Biomedical Sciences, 1999

NJIT: BS Engineering Science, Newark, NJ - Magna cum Laude, 1997

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