Jose A PaulinoPurdue University
Jose A Paulino was born in the Dominican Republic in 1963. There, he grew up and attended high school at Loyola Polytechnic Institute, graduating with top honors with an associate degree in Agronomy. After graduation, in 1981, he migrated to New York City, USA in search of a better future. He spent one and a half year learning the English language before going to the State University of New York at Oswego, New York to continue his education in 1982. There, he majored in Chemistry and graduate at the top of his class in 1985 with a Bachelor of Science, Suma Cum Laude. After graduation, he taught General Chemistry for one semester while waiting to start graduate school. For graduate school he attended Purdue University in West Lafayette, Indiana. He joined Professor Robert Squires’ research group in the Chemistry Department. His research focus was the determination of thermochemical and kinetic properties of reactive intermediates using gas phase ion/molecule reaction. In the course of this research, he developed specialized mass spectrometry instrumentation and published several papers in such journals as the Journal of the American Chemical Society. He graduated in 1992 with a Doctorate in Physical-Organic Chemistry. Then, he moved to the state of New Jersey where he still resides. He started his industry career at Exxon Corporation and then went into pharmaceuticals Analytical Chemistry research and development. Over more than 15 years he has worked at various pharmaceutical companies with increasing responsibilities in the area of Analytical Chemistry research and development.
· Method Development and Validation to support products and new formulation in the pharmaceutical and chemical industries.
· Characterization and structure elucidation of small and large molecule drug substances and drug products.
· Analytical Chemistry research and development related to pharmaceutical, consumer and medical device products.
· Instrumentation for mass spectrometry, chromatographyand spectroscopy.
· Various dosage forms, including solid, liquid, topical, parenteral, combination devices, and consumer products.
· Extractable and leachable studies for device components, container/ closures systems and manufacturing contact materials.
· Stability indicating methods for the assay of active pharmaceutical ingredients and related impurities (small and large molecules) in complex matrixes, such as micro-encapsulated polymer, botanical extract and multiple actives pharmaceutical formulations.
· Implementation of regulatory guidelines to support specifications for release and stability of raw materials, drug substances and finished products, such as GLP, cGMP and CFR 21 Part 11 regulations.
· Inorganic elementalanalysis by ICP-OES, ICP-MS, Flame-AA, and XRF
· Organic analysis by Ion chromatography, FT-IR, Karl Fischer, thermal analyses, titrations, UV/ Vis, GC, GC-MS, HPLC, UPLC, and LC-MS-MS.
– Present (1 year 3 months)North Brunswick, NJ
Analytical Chemistry development in support of the company product line, including innovative methods to determine trace level extractable and leachable impurities.
– (1 year 2 months)Dayton, New Jersey
Analytical Chemistry Manager for Research and Development in support of the company's products, including the following: small and large molecules, drug substances, drug products, release and stability specifications, method development, method validation, method transfer, chromatography, spectroscopy, mass spectrometry interpretation, wet chemistry, and project management.
– (3 years 4 months)Raritan, NJ
Analytical Chemistry Research and Development and QC management for: small and large molecules, drug substance and drug products, release and stability studies, method development and validation in chromatography, spectroscopy, mass spectrometry, electrophoresis, and wet chemistry, project management, and process improvement.
– (11 months)Fairfield, NJ
Project Manager for the Chemistry Department in the Life Science Testing Division of SGS. Additionally, managed the chemistry laboratory for the Consumer Products Testing Division of SGS.
– (6 years 7 months)
Project Manager for Analytical Research and Development in support of pharmaceutical products and drug substances.
– (2 years 1 month)
Managed an Analytical Research and Development group responsible for several drug products and drug substances, method development, method validations, CMC documentation for NDA, and testing to support stability studies and for clinical release.
– (5 years 1 month)
Analytical Research and Development in support of pharmaceutical products
– (2 years)
Technical services to support product line as well as research and development activities.
Journal of Chromatography AFebruary 4, 2013
Commercially available protein reference standard materials are widely used for the quantitation of intact proteins in biopharmaceuticals, food, and consumer products. However, the purity of protein reference standard materials are often assumed to be 100% or they may be assigned an inaccurate value because the methods used to determine protein purity often lack specificity and accuracy. In this...more