Thad Yousey has over 12 years of experience developing and validating assays for clinical studies in the pharmaceutical industry. He has worked at Quintiles, Bristol-Meyers Squibb, and Prevalere developing methods for analyte extraction and detection using LC/MS/MS and other techniques. His responsibilities included optimizing extraction methods, mass spectrometry parameters, and chromatography to support drug discovery, clinical trials, and FDA submissions. He is proficient in various software and instrumentation used in bioanalytical method development and validation.

1. Thad Yousey
968 Poplar Ridge Road  Aurora, NY 13026  (315) 525-9251  tyousey@yahoo.com
SENIOR DISCOVERY SCIENTIST
Experienced Pharmaceutical Research and Assay Development
Over twelve years of experience thoroughly researching, developing, validating and documenting assays
for GLP pharmacokinetic and pharmacodynamic clinical studies focusing on precision, accuracy, high
throughput and streamlined assay reproducibility of Phase 0-4 analytes of interest. Developing and
validating assays for preclinical experimental compounds and pro drugs. Developing and generating
methods, validations and all documentation in support of cGMP methods with strict adherence to FDA
and ICH guidelines. Performing validation confirmations of cGMP assays to support production line
quality control methods.
Experience
QUINTILES -- Ithaca, NY
Senior Discovery Scientist, 07/11/2007 to 04/19/2015
Eight years developing bioanalytical GLP and non GLP methods for analyte extraction from biological
matrices utilizing LC/MS/MS detection. These methods were ultimately used for the generation of
pharmacokinetic data by some of the world’s largest pharmaceutical providers to support; data in client
drug discovery, maximizing accuracy of Cmax and AUC values for future clinical study drug delivery,
substantiate NDA submissions and/or provide data sets for currently marketed compounds (FDA
requirements). Basic duties included:
• Structural confirmations of analytes, precursors, adducts (if present), ion polarity(ies) functionality
and product ions - utilizing LC/MS/MS (turbo ion spray and heated nebulizer)
• Developing and optimizing mass spectrometric methods and parameters in tandem with HPLC
• Developing and optimizing HPLC methods (reversed, normal phase, HLIC, ion pairing) and
parameters assessing; resolution, capacity factor, peak selectivity, highest throughput, API and or
APCI compatibility and client timeline/demands
• Developing/validating chiral and isomeric selective HPLC assays including confirmation of all
chromatographically resolved species
• Researching, developing and validating methods of extraction for analytes, metabolites internal
standards (analogue and stable labeled) and/or pro-drugs from biological matrices to be utilized in
LC/MS/MS detection
• Presenting data to pre-validation committee for approval to move into validation phase
• Interfacing and/or coordinating with clients, directors, wet lab and scientific staff, project leaders
and project managers on trouble shooting, scientific and technical solutions to enhance efficiency
and communication thus decreasing resources, data processing and generation time and ultimately
increasing cost effectiveness
• Maintaining and calibrating instrumentation and documenting procedures following Quintiles
standard operating procedures (SOP)s

2. Bristol-Meyers Squibb – East Syracuse, NY
Analytical Chemist, 06/24/2005 to 12/31/2006
Two years validating cGMP-HPLC, PDA, GC methods of currently marketed off patent drugs
manufactured by BMS and its subsidiaries. Responsible for the re-validation of these GMP methods using
as accurate criteria as possible to duplicate validation data sets collected decades before. Validations
performed at request of upper BMS management to resolve questions posed by the FDA of the validity of
current QC testing. Basic duties included:
• Re-validating pharmaceutical compounds manufactured by BMS following cGMP regulations to
comply with updated Bristol SOPs
• Redeveloping methods for assay and/or impurity determination
• Determining potency/purity utilizing HPLC and GC
• Calibrating and maintaining HPLC, PDA, GC/FID systems and documentation
• Generating protocols and final reports for QA approval
• Optimizing validations which required complete re-validation to enhance one or more cGMP
criteria: range, linearity, precision, accuracy, robustness, repeatability, specificity (selectivity),
LLOD, LLOQ, reproducibility and/or impurity detection
Prevalere (formally Oneida Research Services) – Whitesboro, NY
Scientist II, 04/20/1989 to 05/30/2005
Four years developing bioanalytical GLP methods for analyte extraction from biological matrices. Eleven
years validating assays, extraction and sample analysis from biological matrices. Two years conducting
chlorine and fluorine titrations and combustion analysis in chemical analysis division. Basic duties included:
• Developing and optimizing bioanalytical assays utilizing: LC/MS/MS, GC/MS/MS, GC/FID,
GC/ECD, HPLC (UV/VIS, Fluorescence, Photo diode Array)
• Validation of methods
• Sample extraction and instrument analysis under strict adherence to GLP regulations
• Coordinate with internal departments to ease transition of validation into production
• Systems calibration and maintenance
Equipment Experience
Mass Spectrometers
• AB Sciex LC/MS/MS – 6500, 5500 (ion trap and quadrupole function), 5000, 4000, 3000, 300, III
and III Plus (TIS and heated nebulizer for all instruments above)
• Finnigan TSQ and SSQ 4500 and 4600 series mass spectrometers (coupled to Gas
Chromatography)
• Nermag R10-10C single quadrupole mass spectrometer (coupled to Gas Chromatography)
• VG-Trio bench top single quad mass spec (coupled to Gas Chromatography)
Gas Chromatographs
• Hewlett Packard 5890 and 6890
High Performance Liquid Chromatography
• Shimadzu LC-20AD, LC-10ADvp pumps, Shimadzu SCL-10Avp System Contoller
• Waters 600 Solvent Delivery System, Waters Alliance 2690/2695 Pump/Autosampler
Integrated Unit, Waters 2996 Photo-Diode Array, Waters 486 UV/VIS Detector, Waters 470

3. Scanning Fluorescence Detector
• Perkin-Elmer 200 Pumps/Autoampler
Autoinjection
• LEAP Autoinjectors (injection initiation performed by Analyst, Cycle Composer, or by
LEAP through LEAP controller
Software Experience
Empower (Waters), Analyst 1.6.2 and older versions (Sciex), MacQuan RAD 2.6 and older versions
(Sciex), ExpertEase (Waters), Watson Sample Management System (LIMS system from Thermo),
Cycle Composer (LEAP Technologies),ChemSketch, ChemDraw, MarvinSketch molecular
modeling programs, Microsoft Excel, Word, Power Point
Methodology Experience
Solid Phase Extraction (SPE) Techniques, Liquid/Liquid Extraction (LLE) Techniques, Direct
titration and dilution (cGMP), Dilute/Shoot, Protein Precipitation (solvent protein precip and
protein precipitation plates), some experience with protein binding assays, Cation/Anion exchange
assays and multiple and polar/nonpolar solid phase techniques
Education
PLATTSBURGH STATE UNIVERSITY - Plattsburgh, NY
BA in Environmental Science, 1990
PAUL SMITHS COLLEGE OF ARTS AND SCIENCES – Paul Smiths, NY
AAS, 1986