This document is a resume for Tang N Nguyen, who has over 25 years of experience in pharmaceutical product development, formulation, and manufacturing. They have extensive experience developing formulations across multiple dosage forms including inhalation, ophthalmic, parenteral, and diagnostic products. Their resume highlights leadership roles with increasing responsibility in product development, technology transfer, manufacturing, and ensuring quality and regulatory compliance. They have a proven track record of successfully developing formulations from early stages through commercialization.

1. Tang N Nguyen
(707) 761-2360 (Cell) nguyennhattang@yahoo.com
SUMMARY
Resourceful Pharmaceutical Scientist with extensive formulation experience from early stage
development through clinical studies and commercialization. Strong product characterization, process
optimization, and technology transfer capabilities. Knowledgeable in liquid and suspension formulations,
form-fill-seal, dry-powder-inhaler, and lyophilized dosage forms for inhalation, ophthalmic, parenteral,
and diagnostic products. Committed to fostering a cohesive team environment with strong work ethics
and high levels of reliability and accountability.
PROFESSIONAL EXPERIENCE
Dey, L.P., Napa, California (subsidiary of Mylan, Inc.) 2001 - 2008
Scientist, Pharmaceutical Development
Responsible for formulation development and characterization of various inhalation products. Activities
include experimental design and execution, formulation screening/selection, HPLC analysis and data
evaluation resulting in bringing optimal formulations to effective scale-up and technology transfer to
Manufacturing. Executed manufacture of technical, toxicology, clinical, and registration batches.
• Successfully brought recently developed Formoterol Inhalation Solution to currently marketed
Perforomist™.
 Designed statistical method to characterize the nebulized product by emitted dose (ED) and
Andersen cascade impactor (ACI) demonstrating consistent product performance.
 Analyzed HPLC data of drug delivery for complete aerodynamic particle size distribution (PSD)
providing a comprehensive data package for NDA submission.
• Successfully brought newly developed Formoterol and Fluticasone Inhalation Solution/Suspension
(Combo) to manufacturing Phase III clinical supplies.
 Manufactured Combo formulation at various tox levels and multiple concentrations providing a
comprehensive nebulization program for effective rodent and canine toxicology testing.
 Performed ED and ACI characterization of delivery dose and aerodynamic PSD providing
verification of product performance.
 Microfluidized product and performed aerodynamic PSD study for scale-up studies resulting in
meeting deadlines of aggressive clinical supply schedules.
• Performed Combo formulation feasibility of lipid-dispersed system via micellar solubilization providing
thorough assessment of co-solvent/co-surfactant system and abbreviated stability studies.
• Performed a complete method of ED and ACI characterization of Albuterol dry powder inhaler (DPI)
in early development.
 Verified product performance by completing dose ranging, content uniformity, dose reproducibility,
device reliability, and short/long-term stability studies.
 Completed comprehensive program of special support studies including flow dependence/flow
resistance, customer-use simulation, temperature cycling, temperature/humidity dependence and
handling/shipping effect studies.
 Authored validation report for emitted dose characterization of the product.
Oread Inc., Lawrence, Kansas 1997 - 2000
Manager, Formulation Department
Responsible for formulation study design/performance and facilitating analytical activities to bring
effective formulation development to successful technology transfer and FDA submission
• Developed Paclitaxel formulation used in cancer chemotherapy and effectively transferred the product
to manufacturing site resulting in completion of registration batches.
• Performed pre-formulation/formulation studies of various products for drug substance/product
characterization, solubility, pH rate profile, excipient compatibility, lyophilization cycle development
and abbreviated stability program from early development to successful IND filing.
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2. Tang N Nguyen
(707) 761-2360 (Cell) nguyennhattang@yahoo.com
• Wrote study protocols, completed development reports, generated batch records, and manufactured
batches to monitor progress efficiently throughout the abbreviated stability program.
• Facilitated Bacteriostasis/Fungistasis (B&F), sterility testing, bacterial retention testing, and
antimicrobial preservative effectiveness testing for completion of microbiological assessment.
Taylor Pharmaceuticals, Decatur, Illinois (subsidiary of Akorn, Inc.) 1991 – 1997
Product and Process Development Supervisor
Responsible for performing pre-formulation/formulation and stability studies, verification programs, and
special support studies to submit successful sterile ophthalmic applications to the FDA.
• Developed several ophthalmic formulations from early stage and transferred technology to
manufacturing registration batches for approval of currently marketed products including:
 Antibiotics (Gentamicin and Tobramycin); Mydiatics and Cycloplegics (Phenylephrine HCl,
Cyclopentolate HCl, Atropine Sulfate); Decongestants (Naphazoline HCl); Dye and Test
(Fluorescein Injection); Anesthetics (Proparacaine HCl); Glaucoma (Timolol Maleate)
• Verified product homogeneity by mixing, filtering, and filling throughout the manufacturing process for
successful production of engineering, scale-up, registration and commercial batches.
• Performed filtration optimization, container-closure selection; evaluation of oxygen sensitivity, light
exposure, temperature cycling, and customer-use simulation for effective product development,
process optimization, and special support studies.
• Prepared study protocols, approved batch records, and set up stability programs to monitor progress
efficiently throughout the product shelf life. Partially responsible for write-up of formulation
development process for the CMC and PDR (Pharmaceutical Development Report).
ADDITIONAL EXPERIENCE 1983 – 1991
Production Supervisor, Walnut Pharmaceuticals, Los Angeles, California
Performed/facilitated sterile parenteral and ophthalmic products in “clean room” environment.
Performed drug substance qualification, container-closure systems preparation, product
compounding, filtering, sealing, and distribution of the finished products for labeling and packaging
of several commercial products.
Production Supervisor, V-Tech, El Monte, California
Performed/facilitated EIA (Enzyme Immuno Assay) diagnostic products. Monitored antibody
purification; product compounding, filling, and freeze-drying; reagent dispensing, component
assembling, and labeling-packaging finished products.
Chemist, Diagnostic Products Corp., Los Angeles, California
Performed antibody purification via liquid chromatography (lock-and-key affinity). Coupled purified
antibody with latex beads to produce EIA products for different diagnostic kits. Assisted in tablet
manufacturing operation. Compounded, filled, and lyophilized various serum based calibrators and
antiserums for a complete package of several marketed EIA & RIA (Radioactive Immuno Assay)
products.
EDUCATION
Bachelor of Science in Chemistry from University of Pittsburgh, Pennsylvania (1983 candidate).
PUBLISHED PRESENTATIONS
• Aerosol Droplet Size Distribution of Formoterol Inhalation Solution using Different Nebulizers, Tang
Nguyen and Partha S. Banerjee. Poster presentation at AAPS, 2003.
• In-vitro Performance of Formoterol and Fluticasone from an Inhalation Solution by Nebulization and
Other Inhalation Delivery Systems, Tang Nguyen, Melisa Barron, John Miyawa, and Partha S.
Banerjee. Poster presentation at AAPS, 2003.
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