TOSHIE SHINTANI
Oak Ridge, NJ ****8
973-***-**** ***********@*****.***
PROFESSIONAL SUMMARY
Experience in HPLC, GC, FT-IR, FT-IR:MCT/A, NIR, UV-VIS, Dissolution and other instrumentation and wet analysis. Working Knowledge of cGMP and GLP activities. Self-motivated analytical chemist with quick to learn new techniqus.
Familiar with QC, R&D and product development environment. MS Office (Word, Excel, Power Point) proficiency.
WORK HISTORY
LOHMANN THERAPY SYSTEMS, QUALITY CONTOL, West Caldwell, NJ
QC Chemist III, 09/2013 to 04/2015
-Performed quality control test on incoming raw materials, intermediates and finished products.
-Identification of foreign matter on the finished products, raw materials and the customer complaint samples.
-Performed purity test by TLC, HPLC, GC and other instrumentation and wet analysis.
-Interpreted test results and recorded lab notebook.
-Maintained compliance with FDA, DEA and EPA.
-Operated and maintained analytical instruments such as HPLC, FTIR, CC and Calorimeter.
LOHMANN THERAPY SYSTEMS, R&D, West Caldwell, NJ
R&D Analytical Chemist, 09/2003 to 09/2013
- Developed analytical methods, performed method validation and method transfers.
- Supported formulation development.
-Authored method validation reports.
- Identification of the Foreign matter on the products/raw materials/customer complaint samples.
-Determined equipment operating efficiency.
-Calibrated and troubleshot laboratory instruments.
NOVARTIS PHARMACEUTICALS, TR&D, East Hanover, NJ
Scientist III, Analytical Research & Development, 05/1982 to 06/1999
-Provided analytical support to formulations in the product development department
-Method validation testing of clinical products at various stages from toxicology evaluation to registration phase.
-Authored method validation reports for completion of validation process.
-Analytical lead for method transfers and investigations.
-Project lead for cleaning verification method development and validation.
SANDOZ PHARMACEUTICALS, TR&D, East Hanover, NJ
Scientist B, Analytical Research & Development, 01/1982 to 01/1997
-Performed developing, validating and troubleshooting analytical methodology for pharmaceutical dosage forms.
-Kept current on new separation and detection techniques for pharmaceutical dosage forms.
-Provided technical support to group members.
EDUCATION
Bachelor of Science (1977): Chemistry Major
Fairleigh Dickinson University-New Jersey
ADDITIONAL STRENGTH
Member of American Chemical Society