JAVIER GONZALEZ COMPTE

**** ***** ***** **** ***. 1098 Austin, TX 78704 724-***-****

ac0b3l@r.postjobfree.com

RESEARCH QUALITY CONTROL PROJECT ADMINISTRATION

●B.S. in Biochemistry offering understanding of FDA approval processes and international lab experience in quality control, research & development

●Strong quantitative skills with interests in big data analysis. Understanding of protocol and best practices for lab research including GCP, GMP, cGMP, ISO, and ICH Guidelines.

●Outgoing team player with strong interpersonal skills and an interest in training others. Dual citizenship in U.S. and El Salvador.

EDUCATION

SETON HILL UNIVERSITY, Greensburg, PA May 2014

Bachelor of Science in Biochemistry.

Francesca Brownlee Presidential Scholarship (50% tuition). Varsity Soccer (Division II). Salvation Army volunteer.

Coursework Highlights: Biochemistry, Organic Chemistry, Inorganic Chemistry, Genetics, Molecular Biology, Thermodynamics, Quantum Mechanics

Continuing Education Certificates

The Data Scientist’s Toolbox by John Hopkins University on Coursera. Certificate earned on January 8, 2017.

Drug Development by University of California, San Diego on Coursera. Certificate earned on January 23, 2017.

EXPERIENCE

INSYS THERAPEUTICS, INC. Austin, Tx 2015 - Present

Pharmaceutical company focused on development and manufacturing of therapeutic drugs to treat conditions including cancer and epilepsy.

API Manufacturing Technician January 2017 - Present

●Help synthesis/purification of delta9, delta8-THC, and Cannabidiol.

●Operations: Part of the team ensuring seamless continuity between manufacturing production shifts. Serve as one of the team’s liaisons between Quality Assurance, Quality Compliance, and Operations teams to ensure seamless continuity between manufacturing production shifts.

●Quality Assurance: Follow procedures for handling DEA controlled substances, ensure environmental safety and integrity of production lines, and data review of purification analysis assays.

●Compliance: Adhere to GMP, cGMP, FDA guidelines

●Lab Techniques/Equipment: HPLC/UV, UV/Vis, Rotary Evaporators, Novasep Hipersep

QC Chemist (Contract) November 2015 –April 2016

●Helped analyze raw materials and active pharmaceutical ingredient for final drug products as well as drugs in development. Contribute to writing SOP procedures, certificates of analysis and design experiments.

●Compliance / Quality Assurance: Handled DEA controlled substances I-IV, working across the manufacturing process from performing maintenance on instruments and swabbing manufacturing equipment to ensure clean room integrity to sampling raw material in a clean room and reviewing data from testing.

●Operations: Following GMP, cGMP, FDA guidelines, Clean room guidelines

●Lab Techniques/Equipment: HPLC/UV, GC, UV/Vis, TOC, Polarimeter and wet chemistry, USP tests.

ICDE, San Salvador, El Salvador Nov 2014 - April 2015

Chemist for contract provider of QC services and validation methods for Latin American pharmaceutical companies

●Helped analyze prescription medicine sent from pharmaceutical companies for quality control and pre-market validation. Worked with chemists to review ten medications with indications for gastrointestinal conditions. Also provided quality assurance services for monitoring stability control under ISO guidelines

●Operations: Followed GMP, cGMP, and USP guidelines as well as international ICH guidelines for human drugs.

●Lab Techniques/Equipment: HPLC/UV, AAS, UV-Vis. Refined pipetting, centrifuges. Also gained familiarity with a calorimeter and Atomic Absorption machines.

JAVIER GONZALEZ COMPTE Page 2

SETON HILL UNIVERSITY, Department of Chemistry, Greensburg, PA Sept. 2013 - May 2014

Research Assistant for Physical Chemistry Professor Diane Miller

●Studied impact of changes in the composition of magnetic fields of carbon rings. Work confirmed that changing the position of a substituent (branch of a chemical group in a ring of carbon) modifies the polarity, resulting in different interactions with other molecules. Research implications of finding could expand techniques for studying the behavior of fluorescent molecules.

●Presented research results at student poster sessions at PITTCON Chicago 2014 (large annual conference for laboratory science) and American Chemical Society (ACS) 2014 meeting in Dallas

LABORATORIOS ARSAL, San Salvador, El Salvador 2010, 2013

One of El Salvador’s largest Pharmaceutical companies

Research Assistant in Research and Development, May 2013 - August 2013

●Worked on three projects with full-time Research & Development staff

●Competitive Analysis: Conducted research of patents and analytical methods for development of new drugs, with a focus on techniques for a reformulation of a vitamin B ampoule that treats back pain and nervous system conditions.

●Lab Work: Tested methods for vitamin B ampoule reformulation using HPLC-UV

Lab Assistant Quality Assurance June 2010 - August 2010

●Worked under Ph.D. to monitor environmental safety of physical plant

●Environmental Testing: Conducted daily tests of water quality at three-hour intervals to ensure optimal plant conditions and compliance with regulatory guidelines.

●Quality Control: Ran tests on sugar levels of electrolyte solutions sold OTC at pharmacies throughout Central America.

SKILLS

Language: Fluent in Spanish

Software: ChemDraw, HyperChem, LabArchives. Microsoft Excel, PowerPoint. Apple Keynote, Pages, Numbers, OpenLab, Python, R

JAVIER GONZALEZ COMPTE

INSTRUMENTATION EXPERIENCE AND LABORATORY SKILLS

INSTRUMENTATION

Gas Chromatograph:

GC-2013 Shimadzu with AOIC-20i auto injector

Mini Gas Chromatograph:

Vernier Mini GC with Vernier

Agilent Technologies7890AGC

Logger Pro as software

OpenLAB software

Mass Spectrometer:

GC/MS Shimadzu GC17A GCMS QP5050 with AOC-20i auto-injector

Liquid Chromatograph:

HPLC Perkin Elmer Series 200 divided into three components

(Series 200 Autosampler, Series 200 UV/Vis detector, Series 200 pump)

HPLC Agilent Technologies 1260 Infinity

OpenLab software

U-HPLC Thermo Scientific Accela

Atomic Absorption:

Perkin Elmer atomic absorption spectrometer 3100

Dissolution Station

Hanson Research SrR8-Plus Dissolution Test Station

UV/Vis Spectroscopy:

UV-240PC Shimadzu

Thermo Scientific Genesys 10S

IR Spectroscopy:

Spectrum BX FT-IR Perkin Elmer

IR Affinity-1 FTIR Shimadzu with ATR miracle single reflection horizontal

Thermo Scientific Nicolet is10 with smart omni sampler

Spectrophotometry:

Vernier SpectroVis Plus with Vernier Logger Pro as software

NMR:

NMR EFT-60 Anasazi instruments

Varian EM3601A NMR spectrometer (magnet)

Electrolytic Analyzer:

Sargent-Slomin

Fluorometer:

Perkin Elmer Luminescence Spectrometer LS30

Refractometer

Polarimeter:

Rudolph Research Analytical polarimeter

TOC:

GE Sieves TOC

LABORATORY SKILLS

Aliquoting biological samples

Enzyme Assays

Electrophoresis-Sergeant

PH meter

Bacteria cultures

QPCR (Real-time Polymerase Chain Reaction)

PCR (Polymerase Chain Reaction)

Yeast Cultures

Clean room

Water chemistry

Glove Box operation

PROTOCOLS

GMP (Good Manufacturing Practice)

Clean Room Environments

cGMP (Current Good Manufacturing Practice)

ISO (International Organization for Standardization)

ICH Guidelines (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)

Clean Room Guidelines

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