Miami, FL 33184 M: 305-***-****
Experienced Chemist with wide knowledge of analytical chemistry techniques. Skilled in method validations for Quality Control lab environment and testing raw material, finish product and stability samples. Meets or exceeds all project deadlines. Known as a mentor and trainer, diligent worker and an insatiable appetite for continuous growth and learning. Key strengths and competencies include:
• HPLC • FTIR • Karl Fisher Titrino
• GC • Ionscan • AA
• LIMS • UV – VIS
• Sotax for C.U. • cGMP / FDA Regulations
• Sotax AT-70 for dissolution
WATSON PHARMACEUTICALS, Sunrise, FL Jun 2011- March 2012
Chemist III, Lab Technical Services (LTS)
• Analytical Method Validation\Verification, Method transfer, protocols and reports. Temporary position.
AVEMA PHARMA SOLUTIONS, Miami, FL Sep 2010- Jan 2011
Manager, Analytical Development Lab R&D, Doral, FL
• Qualification of OTC products by USP methods. This position and the lab were eliminated due to an organizational restructuring.
MEGA PHARMACEUTICALS, Miami, FL June 2010- Sep 2010
Analyst, QC Lab, Doral, FL
• Worked in HPLC Method Developments, validations, method remediation, of Nutraceuticals and Dietary Supplements.
• Regular testing using FTIR, UV Spectrophotometer and HPLC.
TEVA PHARMACEUTICALS (formerly IVAX), Miami, FL (1995-2010)
Scientist II, Analytical Services Department, Doral, FL
• Worked in Method Developments, method validations, method transfers, cross-over studies product qualification including writing protocols and reports.
• Methods included Cleaning Validations, Assays, Force degradation and Peak Purity studies, Impurities / Degradants, Dissolution, Residual Solvents, using Ionscan LS, Agilent HPLC and GC systems with ChemStation, Total Chrom and Empower Software and periodical calibration and maintenance of the instruments.
• Provided assistance and training to several Chemists.
Technical Specialist II, Analytical Services Department, IVAX Corporation, Doral, FL (2001-2006)
• Worked in method Developments, method validations, method transfers, cross over studies and their reports.
• Methods include Cleaning Validations, Assay, Impurities / Degradants, Dissolution, Residual Solvents, using Agilent HPLC and GC systems with ChemStation and Total Chrom Software and periodical maintenance and calibration.
• Provided assistance and training to several Chemists.
Quality Control Senior Chemist, IVAX, Doral, FL (2000-2001)
• Carried out routine testing of Raw Materials, stability samples, in-process and finish products samples including the use of Shimadzu HPLC systems/Turbo Chrom software, Dissolution Baths, UV and IR instruments, Karl Fisher Titrino and periodical maintenance and calibration.
• Performed all testing according to standard operating procedures in a laboratory with strict compliance to all cGMP principles.
Quality Control Analyst, Pralex Corporation, (subsidiary of IVAX), St. Croix, USVI (1995-2000)
• Worked in testing of Raw Materials, stability samples, in-process and finish products samples including the use of Hewlett Packard systems / Chem Station software, Vankel Dissolution Baths, UV and IR instruments, Karl Fisher Titrino and periodical maintenance and calibration.
• Performed testing done according to standard operating procedures in a laboratory with strict compliance to all cGMP principles.
• Implemented some methods improvement, Method developments and validations, by HPLC, and wrote reports.
• Created several Excel spreadsheets that were validated and approved.
• Trained several Chemists in the different analytical techniques.
MINISTRY OF PHARMACEUTICAL INDUSTRY, Havana, Cuba 1991-1994
Senior Researcher, Steroid Development Research Laboratory
• Worked in semi-synthesis of steroids and analysis of their Raw Materials Intermediates and final product.
NATIONAL CENTER OF SCIENTIFIC RESEARCH (CNIC) 1988-1994
Senior Researcher, Steroid Development Research Laboratory.
• Was in charge of fermentation and semi-synthesis research analytical support. HPLC (Waters) and GC (Shimadzu) method development and validation.
PRIOR TO: 1988
LABORATORY “MARIO MUNOZ”, PHARMACEUTICAL INDUSTRY MINISTRY
• Developed photochemical research. This included extraction at laboratory and Pilot Plant scale, isolation and structural elucidation of organic compounds, such as alkaloids, steroids, flavonoids, and essential oils (terpenoids) from medicinal plants.
CHROMATOGRAPHIC AND SPECTROSCOPIC EXPERIENCE
• High Performance Liquid Chromatography (HPLC)
• Gas-Liquid Chromatography (GC)
• Ionscan LS
• Thin Layer Chromatography (TLC)
• Mass Spectrometry (MS)
• Nuclear Magnetic Resonance (NMR)
• Atomic Absorption (AA)
• Ultraviolet (UV)
• Infrared (FTIR)
EDUCATION / CERTIFICATION
University of Havana, Cuba. Licensed in Chemistry.
Certified as Auxiliary Research Investigator by Cuban Academy of Science.
Post Graduate Courses:
Statistical and Experimental Design ● Computation Techniques for Chemists
Phytochemical Screening Methods ● High Performance Liquid Chromatography
Chemistry and Pharmacology of Natural Products ● Nuclear Magnetic Resonance C13
Advance Organic Chemistry ● Spectroscopy and its Application to Natural Products
Centrifugation and Filtration Process ● Natural Products ● Steroids
Introduction to 1100HP Troubleshooting and Maintenance, St. Croix USVI
The Chemistry Educational Seminar series from Water, Miami, Feb. 2005
Beyond Fast LC from Dionex, Miami, Nov, 2007.
Introduction to Ionscan LS from Smith Detection, Miami, July, 2007
Ionscan LS from Smith Detection, Warren, NJ, Sep, 2007
Diffuse Reflectance Accessory from Perkin Elmer (FTIR), Miami, Sep. 2008
LIMS, Miami, June 2008.
Sotax AT70, Miami, March 2009.
Storage and Shipping Hazardous Waste, Miami, June 2009.
Chemstation ● Totalchrom ● Empower ● LC Solutions ● IMstation (for Ionscan-LS) ● MS Excel ● MS Word ● MS PowerPoint.